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Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00004144
First received: December 10, 1999
Last updated: April 22, 2014
Last verified: April 2014
  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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004144

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

Additional Information:
Publications:
Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00004144     History of Changes
Other Study ID Numbers: CDR0000067375, P30CA022453, WSU-Z-2021, NCI-T99-0014
Study First Received: December 10, 1999
Last Updated: April 22, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 20, 2014