Bryostatin 1 in Treating Patients With Stage IV Breast Cancer

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: bryostatin 1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003205

97-0751.cc

NCI-T97-0063

UCHSC-97751

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Determine the clinical response of patients with stage IV breast cancer to bryostatin 1. Determine the efficacy of this regimen in these patients. Estimate the pharmacokinetic parameters of bryostatin 1 when given as 24 hour infusion. Determine the ability of this regimen to regulate lymphocyte function in these patients. Determine the effect of this regimen on platelet function and protein kinase C activity in these patients.

OUTLINE: Patients receive bryostatin 1 IV over 24 hours. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4-8 weeks for tumor response.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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