- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004144
Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer.
- Access the pattern of toxicity of this drug regimen in this patient population.
- Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen.
- Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine.
OUTLINE: This is a dose escalation study.
Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects.
PROJECTED ACCRUAL: Approximately 2-3 patients per month will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies
- Measurable or evaluable disease
- Clinically controlled brain metastases allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 8.0 g/dL
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal)
- AST less than 2.5 times ULN
Renal:
- Creatinine normal
Cardiovascular:
- No active cardiac disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent bacterial infection requiring antibiotics
- No serious concurrent medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- Prior hormonal therapy allowed
- No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids)
Radiotherapy:
- At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered
- No concurrent radiotherapy
Surgery:
- Recovered from prior major surgery
Other:
- No concurrent antiviral nucleosides
- At least 1 month since prior investigational agents
- No other concurrent experimental medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bryostatin 1 & gemcitabine hydrochloride
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Philip A. Philip, MD, PhD, FRCP, Barbara Ann Karmanos Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067375
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-Z-2021
- NCI-T99-0014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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