Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of temsirolimus when given together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as temsirolimus and bryostatin 1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Everolimus; Sirolimus

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