Status:
COMPLETED
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Undifferentiated Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and recommended phase II dose of 17-AAG administered as a 60 or 120-minute intravenous infusion on days 1, 4, 8, and 11, of a 21-da...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00079404
Start Date
March 1 2004
Last Update
June 5 2013
Active Locations (1)
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1
COG Phase I Consortium
Arcadia, California, United States, 91006-3776