NCT00003205

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1998

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 23, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

May 30, 2013

Status Verified

December 1, 2002

Enrollment Period

6 years

First QC Date

November 1, 1999

Last Update Submit

May 28, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

bryostatin 1DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bryostatin 1

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Andrew S. Kraft, MD

    University of Colorado, Denver

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 23, 2003

Study Start

April 1, 1998

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

May 30, 2013

Record last verified: 2002-12

Locations

US(1)