Clinical trial · Interventional
Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer
NCT00003205CI-TRIAL-00010477completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.