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17-N-Allylamino-17-Demethoxygeldanamycin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, or Myelodysplastic Syndromes

2014-08-27 03:53:51 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 17-N-allylamino-17-demethoxygeldanamycin may also help cytarabine kill more cancer cells by making cancer cells more sensitive to the drug. Giving 17-N-allylamino-17-demethoxygeldanamycin together with cytarabine may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndromes.

Description

OBJECTIVES:

- Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with cytarabine in patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, or high-grade myelodysplastic syndromes.

- Determine the toxic effects of this regimen in these patients.

- Determine, preliminarily, the activity of this regimen in these patients.

- Correlate the pharmacokinetics of this regimen with cytochrome p450 3A5 genotype in these patients.

- Determine the effect of this regimen on client proteins in vivo and ex vivo using leukemic blasts from patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

Patients receive induction therapy comprising cytarabine IV continuously on days 1-5 and 17-AAG IV over 1 hour on days 3 and 6. Patients achieving a morphologic complete response with incomplete blood count recovery (CRi) or partial response may be eligible to receive a second induction course of therapy after day 21 at the discretion of the principal investigator. Patients achieving a complete response (CR) receive up to 4 courses of consolidation therapy with cytarabine and 17-AAG. Consolidation therapy repeats approximately every 60 days in the absence of disease progression or unacceptable toxicity. Patients who achieve CR and remain in remission for ≥ 6 months may be retreated with cytarabine and 17-AAG (at the current dose level or the maximum tolerated dose [MTD]) at the time of relapse.

Cohorts of 3-6 patients receive escalating doses of 17-AAG until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 3-42 patients will be accrued for this study within 2.1 years.

Study Design

Primary Purpose: Treatment

Conditions

Leukemia

Intervention

cytarabine, tanespimycin

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Maryland
United States
21231-2410

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:51-0400

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