17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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