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

Inclusion 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