Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2004-04-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with stage IV breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bryostatin 1

Criteria

DISEASE CHARACTERISTICS:

• Unequivocal diagnosis of metastatic breast cancer

• Bidimensionally measurable disease

• No uncontrolled CNS metastases

• No disease that is evaluable only, including blastic bone disease, malignant ascites, and malignant pleural effusion

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Menopausal status:

• Not specified

Performance status:

• SWOG 0-2 OR

• Karnofsky 60-100%

Life expectancy:

• At least 18 weeks

Hematopoietic:

• Platelet count at least 50,000/mm^3

• PT and PTT within normal limits

• Neutrophil count at least 2,000/mm^3

Hepatic:

• Bilirubin no greater than 1.2 mg/dL

• Transaminases no greater than 3 times normal

Renal:

• Creatinine no greater than 1.6 mg/dL OR

• Creatinine clearance at least 70 mL/min

Other:

• No active infections requiring antibiotics

• No viral hepatitis allowed

• Seronegative for hepatitis B or C

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 2 months following study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• 2 prior chemotherapy regimens for metastatic disease allowed as adjuvant therapy or for advanced disease (may include high dose chemotherapy with stem cell support)

• At least 4 weeks since prior chemotherapy

• At least 6 weeks since prior nitrosourea or mitomycin therapy

• No other concurrent chemotherapy

Endocrine therapy:

• 2 prior hormonal therapy regimens for metastatic disease as adjuvant therapy or for advanced diseases allowed

• At least 2 weeks since prior hormonal therapy (at least 4 weeks in case of disease progression while receiving hormonal therapy after initial response)

• No concurrent hormonal therapy except oral contraceptives

• No concurrent use of steroids except for management of severe or life- threatening toxic effects arising from bryostatin 1

Radiotherapy:

• At least 2 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No concurrent use of drugs known to interfere with platelet function, such as aspirin or NSAIDs (including ibuprofen)

• No concurrent use of anticoagulants

• At least 2 weeks since prior use of aspirin

• At least 2 days since prior use of NSAIDS

• Concurrent use of acetaminophen to control pain is allowed

• If acetaminophen inadequate for pain control, concurrent use of oral narcotics such as codeine or oxycodone is allowed