Search Results Within Category "Cancer"
Suggestions within category "Cancer"
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
COG ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
• ages 2 to 21 at time of starting the study
• diagnosis of low-grade glioma or low-grade astrocytoma brain tumor
• tumor size increased or returned after treatment with at least one cancer therapy
• high blood pressure (hypertension) must be under control
• must be able to swallow whole capsules
• contact study staff for additional criteria
• treatment for another tumor in the past year
• any serious medical or mental health diagnosis, including substance use disorders or ophthalmological conditions (study staff will review)
• women who are pregnant or breast feeding
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study (ACTION)
The study will test dordaviprone (also known as ONC201), a new drug that is being developed for treating people with glioma. ONC201 may help to remove tumor cells without affecting normal cells of the body. ONC201 is a first-in-class drug, which means it is a new drug having unique action.
• body weight at least 10 kg (22 pounds)
• new diagnosis of H3 K27M-mutant diffuse glioma
• started radiotherapy within 12 weeks from the initial diagnosis
• completed radiotherapy within 2 to 6 weeks prior to starting the study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• primary spinal tumor
• diffuse intrinsic pontine glioma (DIPG)
• evidence of leptomeningeal spread of disease or cerebrospinal fluid dissemination
• received whole-brain radiotherapy or proton therapy
• study staff will review additional criteria
A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease
The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.
• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women and men of child bearing age must follow specific requirements for birth control
• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)
This study will investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations. This study is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study with two cohorts: Cohort A followed by Cohort B. The purpose of Cohort A is to provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the correct dose, population, sample size, and endpoint for the confirmatory part of the study (Cohort B). Additional goals for Cohort A are to assess effects of food on drug absorption. The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.
• at least 12 years old weighing at least 40 kg (88 pounds)
• progressive meningioma that is amenable to volumetric analysis
• see link to clinicaltrials.gov for complete inclusion criteria
• progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation - therapy within the next 3 months
• received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening
• see link to clinicaltrials.com for all exclusion criteria
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)