Search Results Within Category "Cancer"
Suggestions within category "Cancer"
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours
This is an early study of a new drug, called [225Ac]-FPI-1434, to treat solid tumors that have not responded to usual treatment. We are testing different doses of the drug and looking at how well it works for treating the cancer and side effects that occur.
• advanced solid tumor that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy
• restricted in strenuous activity but can walk and is able to do light work e.g., light house work, office work
• contact study staff for additional requirements
• inability to perform the required imaging procedures (e.g., inability to lay flat during scan time)
• uncontrolled brain metastasis
• history of organ transplantation, including stem cell transplantation
• other significant medical or mental health diagnosis (study staff will review)
NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.
• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting (DiRECT)
This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.
• self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA), or Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• current diagnosis of invasive cancer at stage I-IV
• scheduled to receive anti-PD-1/-L1 ICI-containing therapy as standard of care treatment alone or in combination with co-treatments
• identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• diagnosed with melanoma (because melanoma is very rare in AAs)
• received prior immunotherapy for cancer,
Treatment of Refractory Nausea
We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.
• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.
• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)
We are studying an internet-based pain coping skills program with pain education for cancer survivors who have persistent pain. Pain severity and interference will be compared to people who receive only pain education. The pain coping program has 8 sessions that are completed in the first 10 weeks of starting the study. The group that receives only pain education will receive access to the program after 6 months. Everyone is followed for 9 months
• diagnosis of invasive cancer that has been treated with either single therapy or any combination of surgery, radiation, chemotherapy/drug therapy
• may be either off all treatment OR actively receiving anticancer therapy in an adjuvant (after surgery) setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive
• less than/equal to 5 years since the completion of their anticancer therapy
• experiencing continued pain
• cancer history of only superficial skin cancers or in situ malignancy
• only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia)
• known or suspected diagnosable substance use disorder or opioid overuse disorder
• enrolled in hospice care or end-of-life palliative care
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer
We are studying how well radiation therapy with or without olaparib works in treating people with inflammatory breast cancer. Olaparib may keep cancer cells from repairing themselves, making them die. We want to see if adding this drug to radiation therapy is more effective.
• diagnosis of inflammatory breast cancer without distant metastases
• completed neoadjuvant chemotherapy prior to mastectomy
• radiation therapy has not been given to the affected breast
• able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication
• active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
• history of uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or extensive interstitial bilateral lung disease
CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease (MRD)
We are enrolling people who have had complete surgical removal of a stage II or stage III colorectal cancer. We will draw blood samples for circulating tumor DNA (ctDNA) to find out if this blood test can be used to detect recurrence of the cancer. People will be followed for at least 3 years and up to 5 years.
• diagnosis of cancer of the colon or rectum (CRC)
• complete surgical resection, with last surgery occurring within 180 days prior to enrollment
• started adjuvant (after surgery) therapy for current CRC diagnosis
• women who are pregnant or breastfeeding
• history of any invasive cancer except non-melanoma skin cancer
A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
We are comparing treatment of early stage, hormone positive breast cancer with and without radiation therapy. One group will receive radiation therapy with endocrine therapy and the other group will receive endocrine therapy alone. We want to find out if there is any difference in how often breast cancer recurs in the same breast.
• completed surgery to remove a breast tumor and there isn't any evidence of remaining tumor.
• Early stage (T1) tumor without lymph node involvement and a Oncotype DX Recurrence Score of less than or equal to 18
• ER and/or PgR positive and HER2 negative tumor
• tumor size larger that T1
• surgical procedure was a mastectomy
• any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy given for the currently diagnosed breast cancer prior to study entry
• Women who are pregnant or breast feeding
Increasing HPV vaccination coverage among pediatric, adolescent, and young adult (PAYA) cancer survivors: A multilevel intervention
The purpose of this research is to test the efficacy of different interventions to increase vaccination against human papillomavirus (HPV). Survivors of childhood, adolescent and young adult cancers are at increased risk of developing HPV-associated secondary cancers, but have lower HPV vaccination coverage compared to the general population. Interventions which are found to be successful in this study will be incorporated into future survivorship care to improve adherence to recommend preventive healthcare practices. All research procedures will be conducted remotely (e.g. online).
• current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic
• seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder
• survivor of childhood cancer (diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age
• at least 6 months post-treatment (current treatment for graft-versus-host disease allowed)
• no previous HPV vaccination or incomplete HPV vaccination
• people who are unsure of their HPV vaccination status and are unable to find vaccination records (study staff will review)
• previously completed HPV vaccination series
• unable to read and write in English
• pregnant or plans to become pregnant in the next year
• currently receiving treatment for cancer or hematologic disorder or plan for treatment in next 12 months
• immediate hypersensitivity reaction to any vaccine component (study staff will review)
ANHL2121: Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
• 180 days to < 22 years (at time of study enrollment)
• patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry
• participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
• see link to clinicaltrials.gov for complete inclusion criteria
• LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
• history of solid organ or hematopoietic bone marrow transplantation
• female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
• lactating females who plan to breastfeed their infants are ineligible
• see link to clinicaltrials.gov for complete exclusion criteria
COG ACNS1831 - A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves).
• 2 to 21 years old
• neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing
• newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
• patients must have the ability to swallow whole capsules
• patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant
• women who are pregnant or breast feeding
• patients who have an uncontrolled infection
A Phase II, Open Label, Two Arm Study of Therapeutic Iobenguane (131I) as Single Agent or in Combination with Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects (OPTIMUM Trial) Protocol Number: MIBG 2014-01 (OPTIMUM)
This will be a Phase II, two-arm, nonrandomized, non-comparative, open-label study in participants ≥ 1 year of age with iobenguane avid, recurrent or progressive high-risk neuroblastoma. Participants not eligible for vorinostat treatment may receive 131I-MIBG as monotherapy.
• at least 1 year old
• diagnosis of iobenguane avid, high-risk neuroblastoma, with recurrent or progressive disease at any time
• frontline therapy includes a minimum of 4 cycles of induction therapy at any time
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• less than 12 weeks after myeloablative therapy with autologous stem cell transplant
• receiving hemodialysis
• women who are pregnant or breastfeeding
• significant active infections including active hepatitis B, or hepatitis C infection, or known infection with human immunodeficiency virus (HIV)
MT2013-09C : Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases
This is a treatment protocol for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. There is no research element except the collection of routine clinical data.
• up to 55 years old
• see link to clinicaltrials.gov for inclusion criteria specific to each type of leukemia
• Radiation Oncology will evaluate all patients who have had previous radiation therapy
• pregnant or breastfeeding
• HIV positive
• study staff will review additional exclusion criteria
Sightline: Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.
The main purpose of the study is to collect blood samples and medical information to help Nucleix in the development of an investigational test that aims to differentiate between individuals at high risk with and without lung cancer.
• Current or past smokers, with at least 20 pack-years
• People who have with either a high suspicion for lung cancer, with surgery planned for biopsy or removal
• People who have lung cancer that hasn't been treated yet
• People who have diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
• Current lung cancer is known to be stage III or IV by pathology.
• People having regular screening to monitor a lung nodule
PEPN2113: A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy
A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy
• patient must be enrolled on APAL2020SC (NCT04726241)
• patients must be between 1 and 17 years of age at the time of study enrollment
• patients, with or without Down syndrome (DS), and with de novo acute myeloid leukemia, therapy-related acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane
• second or greater relapse or refractory AML OR refractory myelodysplastic syndrome (MDS) OR mixed phenotype acute leukemia (MPAL)
• see link to clinicaltrials.gov for complete criteria
• patients who are currently receiving another investigational drug are not eligible
• patients who are currently receiving other anti-cancer agents are not eligible except patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy
• study staff will review additional exclusion criteria
Ten Thousand Families Study
The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.
• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Evaluate the perspectives of cancer survivor patients and caregivers on using an intrathecal drug delivery system as a continuum of pain management care using a qualitative study.
Targeted medication delivery near the spinal cord (intrathecal pump) may be offered for cancer pain treatment in carefully selected patients. Prior studies showed an improved functional status reduction in oral medications and their side effects. Cancer survivors receiving intrathecal pump treatment for pain are eligible to participate in the research and share their stories. After consenting, a interview (45 minutes by zoom) will be conducted before and after the treatment to improve our understanding of patient perceptions of pain treatment with an intrathecal pump.
• cancer survivors with pain for more than 3 months duration who may benefit from intrathecal pump treatment for pain
• people who are not eligible for treatment with an intrathecal pump
GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.
• at least 18 years old
• able to tolerate giving a blood specimen of up to 60 cc
• willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• people who have untreated colon cancer OR have previously removed adenomas, OR have a family history of colon cancer OR have a current positive screening stool test in the past 12 months that hasn't been evaluated
• Healthy Controls: have no history of finding polyps, no family history, or negative colorectal cancer screening test (if performed) within past 12 months
• people who have had surgery, radiation, or chemotherapy for their current colorectal cancer or any other cancer
• history or clinically active Inflammatory Bowel Disease
• HIV or chronic active viral hepatitis
• history of cancer in the past 3 years (except minor skin, cervical, or endometrial)
• active chemotherapy or radiation treatment for any purpose
Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone metastases from Multiple Myeloma
There is no consensus on the radiation dose required to relieve the pain from bone lesions from multiple myeloma. Usually, patients receive between 10 and 12 radiation treatments to achieve pain relief. But a shorter course of radiotherapy may be more effective. This study will evaluate whether pain relief can be achieved using only 1 or 2 radiation treatments, which will be delivered to a painful bone lesion. Your study doctor will decide whether you receive 1 or 2 treatments. The total amount of radiation you will receive will be the same whether it is done in one or two treatment sessions.
• diagnosis of multiple myeloma
• painful bone metastasis that has been confirmed by a xray
• may have had any number of prior chemotherapy/immunotherapy regimens
• at least able to walk and do all selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for additional requirements
• received prior radiation therapy or prior palliative surgery to the bone lesion that is causing pain
• pathologic fracture or impending fracture at the area of the bone lesion causing pain
• women who are pregnant
• additional criteria apply (study staff will review)
COG ARST2031: A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)
This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. Cyclophosphamide is in a class of medications called alkylating agents. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.
• up to 50 years old
• newly diagnosed (Rhabdomyosarcoma) RMS
• see link to clinicaltrials.gov for complete Inclusion and Exclusion Criteria
• evidence of uncontrolled infection
• RMS that is considered a second cancer and previous cancer(s) that were treated with chemotherapy and/or radiation
• patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS
• women who are pregnant or breast feeding
MT-2018-20: COG AALL1631 - International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients (> 1 year and < 21 years) with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
• >= 1 year (365 days) and =< 21 years at ALL diagnosis
• Diagnosis: Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or molecular methodologies. OR
• Diagnosis: ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABLclass fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA.
• see link to clinicaltrials.gov for complete Inclusion Criteria
• known history of chronic myelogenous leukemia (CML)
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Down syndrome
• patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.
• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE HER-2 NEGATIVE BREAST CANCER
This study is looking at how well serum tumor markers work to monitor people who have hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. We want to see if using the markers (from a blood sample) is as good as using scans to monitor disease.
• diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative, metastatic (M1) breast cancer
• receiving or plan to receive first-line systemic treatment for metastatic disease
• no other prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years
• known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia
• known brain leptomeningeal metastases
• must not be pregnant
EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature driven Analysis
We are studying the use of pembrolizumab to treat people who have stage IV non-squamous, non-small cell lung cancer. Pembrolizumab may help the body’s own immune system attack cancer so tumor cells cannot grow and spread. We are looking at when it is most effective to give the pembrolizumab and when to combine it with other anticancer drugs, pemetrexed and carboplatin.
• confirmed stage IV non-squamous non-small cell lung cancer (NSCLC)
• PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells -
• Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC
• EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations
• significant gastrointestinal disorders with diarrhea as a major symptom
• history of auto-immune condition (including Guillain-Barre Syndrome or Multiple Sclerosis) requiring ongoing or intermittent systemic treatment in the past 2 years
• pregnant or breast-feeding
A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer
This study uses different drug combinations to treat women who have endometrial cancer that has come back or has not responded to treatment. The drugs have different ways of stopping the growth of tumor cells and we are looking to see if different combinations are more effective.
• recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments
• following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell histology is excluded
• must have had one prior chemotherapeutic regimen for management of endometrial carcinoma
• Body weight > 30 kg
• able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption
• Prior enrollment into a clinical trial including cediranib or olaparib; Note: prior bevacizumab is not an exclusion criterion
• Pregnant women are excluded
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
We are studying the addition of a drug to the treatment for people who have triple-negative breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells. Some people will receive the current treatment and others will have the current treatment with carboplatin added. The results of the two treatments will be compared.
• breast tumor must have been determined to be estrogen receptor (ER)-and progesterone receptor (PgR)-negative
• tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative
• surgery (mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy) completed no more than 60 days from enrollment
• T4 tumors including inflammatory breast cancer
• clinical or radiologic evidence of metastatic disease
• previous history of invasive breast cancer or DCIS in the same breast
• Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
COG ACNS1833 - A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
The overall goal of this phase 3 non-inferiority study is to assess if selumetinib works as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with low-grade glioma (LGG).
• 2 to 21 years old
• all tumors considered low-grade glioma or low-grade astrocytoma
• patients with metastatic disease or multiple independent primary LGG are eligible
• patients must have the ability to swallow whole capsules
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
COG AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
This phase II trial studies how well combination chemotherapy works in treating patients (≤ 30 years old) with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).This trial may help doctors find out what effects, good and/or bad, regimen UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT)and regimen ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
• patients must be =< 30 years old at study enrollment
• patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor and have received an initial risk assignment showing DAWT or patients with relapsed favorable histology Wilms tumor
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• patients with a history of bilateral Wilms tumor
• patients with any uncontrolled, intercurrent illness
• female patients who are pregnant or breastfeeding
Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'
The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.
• 21 years or older
• Daily user of tobacco or nicotine products
• Unstable health condition
• Pregnant or nursing