Breast CancerPhase 2NCT00003205
Bryostatin 1 in Treating Patients With Stage IV Breast Cancer
A Phase 2 study testing bryostatin 1 in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- bryostatin 1
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Denver, Colorado, 80010
About this study
Official title: A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- bryostatin 1
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bryostatin 1Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2003 (estimated)
- Study startApr 1998
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew S. Kraft, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003205
- Sponsor's protocol ID
- 97-0751.cc
- Other IDs
- UCHSC-97751, NCI-T97-0063
- Status last verified
- Dec 2002
- First submitted
- 1 Nov 1999
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bryostatin-1 for the Treatment of Stage IV Breast Cancer
- ClinicalTrials.gov ID
- NCT00003205
- Acronym / sponsor ID
- 97-0751.cc
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1998
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 23 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bryostatin 1 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew S. Kraft, MD study chair
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bryostatin 1 in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.