17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
Acute Undifferentiated Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Undifferentiated Leukemia
Eligibility Criteria
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
Sites / Locations
- COG Phase I Consortium
Arms of the Study
Arm 1
Experimental
Arm I
Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-120 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.