Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bryostatin 1 Drug: gemcitabine hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar) |
| Study Start Date: | May 2000 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Study Chair: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004144 History of Changes |
| Other Study ID Numbers: | CDR0000067375, WSU-Z-2021, NCI-T99-0014 |
| Study First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Gemcitabine Bryostatin 1 Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on June 18, 2013