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clinical-trial-llm-cancer-v2

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Study Objectives This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or refractory solid tumors or leukemia. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Conditions: Acute Undifferentiated Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: tanespimycin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed diagnosis of solid tumor or leukemia with documented M3 marrow * Histologic confirmation of intrinsic brain stem tumors not required * Relapsed or refractory disease * No known curative therapy * In patients with CNS tumors, neurologic deficits must be stable for at least the past week * Performance status - Karnofsky 50-100% (>10 years of age) * Performance status - Lansky 50-100% (≤ 10 years of age) * For patients with solid tumors: * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions) * For patients with leukemia: * Platelet count ≥ 20,000/mm\^3 (may receive platelet transfusions) * Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min * Creatinine based on age as follows: * ≤ 0.8 mg/dL if ≤ 5 years of age * ≤ 1.0 mg/dL if > 5 years and ≤ 10 years of age * ≤ 1.2 mg/dL if > 10 years and ≤ 15 years of age * ≤ 1.5 mg/dL if > 15 years and ≤ 21 years of age * No uncontrolled infection * No prior severe allergy to eggs * No situation that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * At least 7 days (or window for adverse effects has passed) since prior biologic therapy and recovered * At least 7 days since prior hematopoietic growth factors * At least 2 months since prior stem cell transplantation and no evidence of graft-vs-host disease * No concurrent hematopoietic growth factors * No concurrent biologic therapy * No concurrent immunotherapy * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent steroid therapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 3 months since prior total body irradiation or craniospinal radiotherapy * At least 3 months since prior radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since prior substantial bone marrow radiotherapy * Recovered from prior radiotherapy * No concurrent radiotherapy * No other concurrent investigational drugs * No other concurrent anticancer agents * No concurrent phenytoin or phenobarbital * No concurrent warfarin

Study Objectives The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy. Conditions: Aggressive Fibromatosis, Desmoid Tumor Intervention / Treatment: DRUG: Imatinib Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histological confirmed aggressive fibromatosis (desmoid tumor) * Measurable disease according to the RECIST criteria * Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging * No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required * No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity * Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible * Age > or = 18 years * WHO PS < or = 1 * Effective contraception during study medication * Signed informed consent form Exclusion Criteria: * Surgical intervention < 4 weeks * Prior therapy with imatinib * Pregnancy or lactation * Severe hepatic dysfunction * Known allergic reaction to imatinib or one of its components * The following laboratory values: Absolute neutrophil count < 1.5 x 103/mm3, Platelets < 100,000/mm3, Serum creatinine > or = 2.5 mg/dl, SGOT and/or SGPT > 2.5 x ULN (upper limit of normal), Total bilirubin > 1.5 x ULN * Participation in another study (four weeks before and during the study) * Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix