A Phase 1 interventional study of tanespimycin in Leukemia, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic myelogenous leukemia that did not respond to imatinib mesylate.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open label, dose-escalation, multicenter study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 15 minutes or 1 hour (depending on the dose administered) once on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for up to 3 courses in the absence of unacceptable toxicity or disease progression. Eligible patients may receive additional courses of 17-AAG at the discretion of the investigator.
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 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at the MTD.
Patients are followed for 1 month.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
Browse Leukemia studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 398 studies on the registry; 67 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
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DISEASE CHARACTERISTICS:
Diagnosis of chronic phase chronic myelogenous leukemia
Hematologic resistence after treatment with imatinib mesylate (400 mg per day or maximum tolerated dose [MTD]) as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No severe debilitating pulmonary disease, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 1 week since prior and no concurrent drugs that alter metabolism by cytochrome P450 3A4, including the following:
The record gives a start of Oct 2004 and a completion of Oct 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2005. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tanespimycin
Jonsson Comprehensive Cancer Center →