Acute Myeloid Leukemia Clinical Trial

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

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.

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Full 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-day course, to children with refractory solid tumors or relapsed leukemia.

II. To define and describe the toxicities of 17-AAG administered on this schedule.

III. To characterize the pharmacokinetics of 17-AAG in children with refractory cancer.

SECONDARY OBJECTIVES:

I. To preliminarily define the antitumor activity of 17-AAG within the confines of a phase I study.

II. To assess the biologic activity of 17-AAG. III. To examine the role of CYP3A5 polymorphisms in the pharmacologic and clinical phenotypes observed following administration of 17-AAG to children, within the confines of a phase 1 study.

OUTLINE: This is a dose-escalation, multicenter study.

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.

Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients with leukemia receive 17-AAG at the MTD as above. If these 6 patients tolerate this regimen, another 6 leukemia patients receive 17-AAG IV over 60 minutes on days 1, 4, 8, 11, 15, and 18.

Treatment repeats every 28 days for 17 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

36

Study ID:

NCT00079404

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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COG Phase I Consortium
Arcadia California, 91006, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

36

Study ID:

NCT00079404

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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