Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors
Recurrent Melanoma, Recurrent Renal Cell Cancer, Stage IV Melanoma
About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed solid tumor, including melanoma or renal cell carcinoma Metastatic or unresectable disease Must have evidence of residual, recurrent, or metastatic disease by radiography Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT scan, MRI, or x-ray) OR ≥ 10 mm by spiral CT scan Must show clear evidence of disease progression within the lesion if the only site of measurable disease is within a previously irradiated volume Standard curative or palliative measures do not exist OR are no longer effective No history of or known brain metastases Performance status - ECOG 0-1 At least 3 months WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 AST and ALT ≤ 2.5 times upper limit of normal (ULN) Bilirubin normal Creatinine ≤ 1.5 times ULN Creatinine clearance ≥ 50 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Fasting cholesterol ≤ 350 mg/dL* Triglycerides ≤ 400 mg/dL* Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective contraception for ≥ 1 month before, during, and for ≥ 3 months after completion of study treatment (during and for ≥ 3 months after completion of study treatment for male patients) No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No ongoing or active bacterial or viral infection No psychiatric illness or social situation that would preclude study compliance No dementia or altered mental status that would preclude giving informed consent No other uncontrolled illnesses More than 3 weeks since prior immunotherapy Prior biological therapy (e.g., interferon or interleukin 2, vaccine, antibody-based and tyrosine kinase inhibitors) allowed No concurrent prophylactic hematopoietic colony-stimulating factors except for epoetin alfa No prior cytotoxic chemotherapy No prior bryostatin 1, temsirolimus, everolimus, or AP23573 for this malignancy More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No concurrent steroids except for topical or inhaled use No other concurrent experimental agents No prior radiotherapy to > 25% of bone marrow More than 3 weeks since prior radiotherapy More than 3 weeks since prior major surgery, including nephrectomy Minor surgical procedures allowed Recovered from prior therapy More than 3 weeks since prior other anticancer investigational agents Concurrent CYP3A4 inducers or inhibitors allowed provided patient has been on a stable dose for ≥ 1 week before study entry No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent antineoplastic agents or therapies
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (bryostatin, temsirolimus)
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1. On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.