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Home > "B" Clinical Trials Conditions > Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer  Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PhilipPhilip, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Philip Philip 313-745-9155
Additional Information:
Study ID Numbers: CDR0000067375; WSU-Z-2021,NCI-T99-0014
Study Start Date:
Record last reviewed: July 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004144
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
2. Combination Chemotherapy in Treating Patients With Advanced Cancer
3. Carmustine Implants in Treating Patients With Brain Metastases
4. Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
5. PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
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