A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol

Date de début de l'étude : 1 juillet 1999

DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists Progressive disease evidenced by 1 of the following: Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma) Development of new lesions or an increase in existing lesions No increase in a biochemical marker (e.g., carcinoembryonic antigen, CA-15-3, or an increase in symptoms) as sole measure of disease Prostate cancer (androgen independent) meeting the following criteria: Progressing metastatic disease on bone scan, CT scan, or MRI Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria: At least 3 rising PSA values obtained at least 1 week apart = 2 rising values more than 1 month apart with at least 25% increase over the range of values Serum testosterone less than 30 ng/mL Castrate status should be maintained by medical therapies if orchiectomy has not been performed Progressive disease must be evident off antiandrogen therapy if received prior to study entry Registered to protocol MSKCC-9040 Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists Progressive disease evidenced by 1 of the following: Accelerated or blastic phase disease that is not responsive to standard therapy or loss of hematologic response to imatinib mesylate while remaining in chronic phase for CML Relapsed or refractory after treatment with standard chemotherapy and imatinib mesylate for Ph-positive ALL No active CNS or epidural tumor Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC greater than 3,500/mm^3 Platelet count greater than 100,000/mm^3 No restrictions based on peripheral blood counts for CML and Ph-positive ALL Hepatic: Bilirubin no greater than 1.2 times upper limit of normal (ULN) AST less than 1.5 times ULN Prothrombin time normal Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months Ejection fraction greater than 45% by radionuclide cardiac angiography No ventricular aneurysm or other abnormal wall motion No reversible defect by thallium stress test if any of the following conditions are present: Ejection fraction less than 45% on radionuclide angiocardiography Worrisome but nonexclusive cardiovascular history Abnormal echocardiogram Patients with the following history or clinical findings require additional diagnostic testing: Significant Q waves (greater than 3 mm or greater than one-third of the height of the QRS complex) ST elevation or depressions of greater than 2 mm that are not attributable to hypertension strain Absence of regular sinus rhythm Bundle branch block Requirement for diuretics for reasons other than hypertension or digoxin for reasons other than atrial fibrillation Prior mild to moderate congestive heart failure No New York Heart Association class III or IV heart disease No angina pectoris No uncontrolled hypertension or intermittent claudication No severe debilitating valvular disease Pulmonary: No severe debilitating pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring IV antibiotics No symptomatic peripheral neuropathy grade 2 or higher No other severe medical conditions that would increase risk for toxicity No allergy to eggs or egg products PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy (including interferon for CML) and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (3 days for hydroxyurea for CML or ALL) and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior endocrine therapy and recovered Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy to localized disease sites not being used to evaluate antitumor response allowed No concurrent radiotherapy to only measurable lesion Surgery: See Disease Characteristics Prior orchiectomy allowed No concurrent surgery Other: At least 3 days since prior imatinib mesylate for CML or ALL At least 4 weeks since prior investigational anticancer drugs and recovered At least 4 weeks since prior palliative treatment for metastatic disease No concurrent ketoconazole, warfarin, verapamil, miconazole, or erythromycin No other concurrent investigational drugs