Spots Global Cancer Trial Database for Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

Official Title: Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)

Study ID: NCT00004144

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

bryostatin 1

gemcitabine hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer. * Access the pattern of toxicity of this drug regimen in this patient population. * Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen. * Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine. OUTLINE: This is a dose escalation study. Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects. PROJECTED ACCRUAL: Approximately 2-3 patients per month will be accrued for this study.