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Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004144
First Posted: January 27, 2003
Last Update Posted: April 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Enrollment: 36
Study Start Date: May 2000
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bryostatin 1 & gemcitabine hydrochloride Drug: bryostatin 1 Drug: gemcitabine hydrochloride

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004144


Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
  More Information

Publications:
Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00004144     History of Changes
Other Study ID Numbers: CDR0000067375
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-Z-2021
NCI-T99-0014
First Submitted: December 10, 1999
First Posted: January 27, 2003
Last Update Posted: April 24, 2014
Last Verified: April 2014

Keywords provided by Barbara Ann Karmanos Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Gemcitabine
Bryostatin 1
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic