Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies

• Measurable or evaluable disease

• Clinically controlled brain metastases allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Hemoglobin at least 8.0 g/dL

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal)

• AST less than 2.5 times ULN

Renal:

• Creatinine normal

Cardiovascular:

• No active cardiac disease

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No concurrent bacterial infection requiring antibiotics

• No serious concurrent medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapy allowed

• No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids)

Radiotherapy:

• At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered

• No concurrent radiotherapy

Surgery:

• Recovered from prior major surgery

Other:

• No concurrent antiviral nucleosides

• At least 1 month since prior investigational agents

• No other concurrent experimental medications