Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

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