Status:
COMPLETED
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of frequency, severity, and duration of treatment...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic phase chronic myelogenous leukemia
- Philadelphia chromosome (Ph)-positive disease
- Hematologic resistence after treatment with imatinib mesylate (400 mg per day or maximum tolerated dose \[MTD\]) as defined by 1 of the following criteria:
- Loss of complete hematologic response, defined as WBC count OR platelet count \> upper limit of normal (ULN) on 2 separate occasions at least 2 weeks apart that cannot be attributed to other etiologies
- Absolute increase of ≥ 30% in Ph-positive cells while on a stable dose of imatinib mesylate for at least 6 months\* NOTE: \*Patients meeting this criterion are not eligible for enrollment into the expanded MTD cohort
- Less than 15% blasts in peripheral blood or bone marrow AND \< 30% blasts and promyelocytes in peripheral blood or bone marrow
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- At least 6 months
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin \< 1.5 times ULN (3 mg/dL for patients with Gilbert's syndrome)
- ALT or AST \< 2 times ULN
- No known hepatitis positivity
- Renal
- Creatinine \< 1.5 times ULN OR
- Creatinine clearance \> 60 mL/min
- Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- Pulmonary
- No severe debilitating pulmonary disease, including any of the following:
- Dyspnea at rest
- Significant shortness of breath
- Chronic obstructive pulmonary disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- No known HIV positivity
- No psychological or social condition that would preclude study compliance
- No addictive disorder that would preclude study compliance
- No family problems that would preclude study compliance
- No known allergy or sensitivity to soy or other excipient components of study drug
- No other illness or condition that may affect safety of study treatment or evaluation of study endpoints
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 2 weeks since prior interferon
- No concurrent interferon
- Chemotherapy
- More than 2 weeks since prior cytarabine (4 weeks for doses \> 100 mg)
- More than 6 weeks since prior busulfan
- No concurrent cytarabine
- No concurrent hydroxyurea during the second study treatment course and beyond
- No concurrent anagrelide during the second study treatment course and beyond
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- More than 2 days since prior imatinib mesylate
- More than 1 week since prior and no concurrent drugs that alter metabolism by cytochrome P450 3A4, including the following:
- Diltiazem
- Nifedipine
- Verapamil
- Fluconazole
- Itraconazole
- Ketoconazole
- Lovastatin
- Simvastatin
- Indinavir
- Nelfinavir
- Ritonavir
- Alprazolam
- Diazepam
- Midazolam
- Triazolam
- Phenobarbital
- Phenytoin
- Carbamazepine
- Azithromycin
- Clarithromycin
- Erythromycin
- Rifampin
- Rifamycin
- Astemizole
- Terfenidine
- Amiodarone
- Cimetidine
- Cisapride
- Cyclosporine
- Grapefruit juice
- Hypericum perforatum (St. John's wort)
- Warfarin
- More than 4 weeks since prior investigational drugs and recovered
- No concurrent imatinib mesylate
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00100997
Start Date
October 1 2004
End Date
October 1 2006
Last Update
July 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095