NCT00112476

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

A Phase I Study of Intravenous CCI-779 in Combination With Bryostatin-1 in Solid Tumors (10038414)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of temsirolimus when given together with bryostatin 1 in patients with unresectable or metastatic solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. SECONDARY OBJECTIVES: I. Correlate the extent and duration of inhibition of p70\^S6kinase phosphorylation in peripheral blood mononuclear cells with tumor growth or reduction in these patients. II. Correlate the phosphorylation total and phospho-AKT and total and phospho ribosomal S6 protein (indicators of mTOR activation) with antitumor effects of this regimen in these patients. III. Correlate tumor expression of phospho-ERK1 and -ERK2 with antitumor effects of this regimen in these patients. IV. Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation study of 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. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Conditions

• Recurrent Melanoma
• Recurrent Renal Cell Cancer
• Stage IV Melanoma
• Stage IV Renal Cell Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	bryostatin 1	Given IV
DRUG	temsirolimus	Given IV

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-07-01
• First posted: 2005-06-03
• Last updated: 2013-05-03

Locations

1 site across 1 country: United States