Overview
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
Status:
Completed
Completed
Trial end date:
2006-10-01
2006-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jonsson Comprehensive Cancer CenterCollaborator:
National Cancer Institute (NCI)
Criteria
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