17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring chronic myelogenous leukemia, BCR-ABL1 positive, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
Eligibility 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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA