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

Completed · Phase 1

Conditions studied: Recurrent Melanoma, Recurrent Renal Cell Cancer, Stage IV Melanoma, Stage IV Renal Cell Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00112476

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2005-03-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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