Search Results Within Category "Cancer"
Suggestions within category "Cancer"
PEPN2411; DT2216 (NSC#850950, IND# 170973) in combination with irinotecan for children, adolescents and young adults with relapsed or refractory solid tumors: A Phase 1 study with Phase 2 feasibility cohort for fibrolamellar carcinoma
Primary Aims 1. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DT2216 in combination with intravenous irinotecan in patients with recurrent/refractory solid tumors. 2. To define and describe the toxicities of DT2216 in combination with irinotecan administered on this schedule in patients with recurrent/refractory solid tumors and patients with fibrolamellar carcinoma (FLC). 3. To characterize the pharmacokinetics of DT2216 in combination with irinotecan in patients with recurrent/refractory solid tumors and patients with fibrolamellar carcinoma (FLC). 4. To preliminarily define antitumor activity of DT2216 in combination with irinotecan in patients with recurrent/refractory solid tumors (within the confines of a Phase 1 study) and in patients with recurrent/refractory FLC.
• Phase 1: Relapsed & refractory solid tumor. Age: Patients between ≥ 1 year and ≤ 21 years of age at the time of study. Diagnosis: Patients with recurrent/refractory solid tumors excluding primary central nervous system tumors. Disease Status: Patients must have either measurable or evaluable disease.
• Phase 2: Fibrolamelar carcinoma. Age: Patients between ≥ 1 year and ≤ 39 years of age at the time of study enrollment. Diagnosis: Patients with (FLC), which must include genomic confirmation of the DNAJB1:PRKACA fusion performed at a CLIA-certified laboratory. Disease Status: Patients must have measurable disease.
• Pregnant or breast-feeding women.
• Concommitant meds: Corticosteroids, Investigational Drugs, Anti-cancer Agents, Anti-GVHD agents post-transplant, CYP-450 Interactions.
• Patients with lymphoma.
• Patients who have an uncontrolled infection.
AOST2032; A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin. Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.
• less than 40 years old
• new diagnosis of osteosarcoma of any site
• previous treatment for osteosarcoma
• brain metastasis
• history of high blood pressure (140/90) that has required medication
• women who are pregnant or breast feeding
COG ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
• 21 or younger at time of enrollment
• newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma
• must be enrolled in APEC14B1 (NCT02402244) prior to enrollment and treatment on ARST2032 (this trial)
• contact study team for more detailed criteria
• received prior chemotherapy and/or radiation therapy for cancer prior to enrollment
• unable to undergo radiation therapy
• Females who are pregnant