Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors
Male Breast Cancer, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip
About this trial
This is an interventional treatment trial for Male Breast Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed solid tumor, including, but not limited to, the following: Prostate Breast Ovary Colon Kidney Head and neck Stomach Melanoma Metastatic or unresectable disease No standard curative or palliative therapy exists or is no longer effective Progressive disease as indicated by the following: Non-prostate cancer New lesions or increase in pre-existing lesions on bone scintigraphy, CT scan, MRI, or by physical examination No increase in biochemical markers (e.g., carcinoembryonic antigen or CA-15-3) or symptoms as sole evidence of disease progression Prostate cancer Must have castrate metastatic disease (i.e., disease progression after castration or treatment with a gonadotropin-releasing hormone [GnRH] analog) Patients who have not undergone surgical orchiectomy must continue with medical therapy (i.e., GnRH analogs) to maintain castrate levels of serum testosterone < 50 ng/dL Patients who received an antiandrogen as part of first-line hormonal therapy must show disease progression after discontinuing treatment Progressive metastatic disease on imaging studies (e.g., bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA) allowed Biochemical progression is defined as a minimum of 3 rising PSA values from baseline obtained at least 1 week apart OR 2 rising PSA values obtained more than 1 month apart, with >= 25% increase in value No active brain metastases Hormone receptor status: Not specified Male or female Performance status - Karnofsky 70-100% Performance status - ECOG 0-1 More than 6 months WBC >= 3, 000/mm^3 Absolute neutrophil count >= 1, 500/mm^3 Platelet count >= 100,000/mm^3 Bilirubin =< 1.5 times upper limit of normal (ULN) AST and ALT < 1.5 times ULN PT normal Creatinine =< 1.4 mg/dL Creatinine clearance > 55 mL/min QTc < 450 msec for male patients (470 msec for female patients) LVEF > 40% by MUGA No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row) No myocardial infarction within the past year No active ischemic heart disease within the past year No New York Heart Association class III or IV congestive heart failure No congenital long QT syndrome No left bundle branch block No poorly controlled angina No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs Calcium blockers and beta blockers allowed No other significant cardiac disease Oxygen saturation > 88% Dyspnea < grade 2 at rest on room air No clinically significant pulmonary comorbidity (e.g., severe chronic obstructive pulmonary disease) No requirement for supplemental oxygen Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or ongoing infection No symptomatic peripheral neuropathy >= grade 2 No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) At least 1 week since prior ketoconazole More than 4 weeks since prior radiotherapy Recovered from all prior therapy More than 4 weeks since prior investigational anticancer therapeutic drugs No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent administration of any of the following herbal remedies: Hydrastis canadensis (goldenseal) Hypericum perforatum (St. John's wort) Uncaria tomentosa (cat's claw) Echinacea angustifolia roots Trifolium pratense (wild cherry) Matricaria chamomilla (chamomile) Glycyrrhiza glabra (licorice) Dillapiol Hypericin Naringenin No other concurrent investigational agents No other concurrent anticancer agents or therapies
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (alvespimycin hydrochloride)
Patients receive alvespimycin hydrochloride IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of alvespimycin hydrochloride until at least 1 of 2 patients experience DLT. Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of alvespimycin hydrochloride until MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. Once the MTD is determined, 10 additional patients are treated at that dose.