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Bryostatin and Vincristine in B-Cell Malignancies

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ClinicalTrials.gov Identifier: NCT00003166
Recruitment Status : Completed
First Posted : March 19, 2004
Last Update Posted : January 11, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This phase I trial is studying the side effects and best dose of bryostatin-1 when given together with vincristine in treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or multiple myeloma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells

Condition or disease Intervention/treatment Phase
Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Stage III Multiple Myeloma Drug: bryostatin 1 Drug: vincristine sulfate Other: laboratory biomarker analysis Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of bryostatin 1 as a 24 hour infusion and vincristine when administered sequentially.

II. To determine the effect of this combination on programmed cell death (apoptosis).

III. To determine the immunomodulatory effect of bryostatin 1. IV. To observe patients for clinical antitumor response after giving combination bryostatin 1 and vincristine.

OUTLINE: This is a dose-escalation study of bryostatin 1.

Patients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment. Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator.

Cohorts of 3 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Combination Bryostatin 1 (NSC 339555) and Vincristine in B-Cell Malignancies
Study Start Date : May 1998
Actual Primary Completion Date : July 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (bryostatin 1, vincristine sulfate)

Patients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment. Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator.

Cohorts of 3 patients receive escalating doses of bryostatin 1 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity.

 Drug: bryostatin 1
Given IV
Other Names:
  • B705008K112
  • BRYO
  • Bryostatin

Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. MTD [ Time Frame: 2 weeks ]
  2. Response rates [ Time Frame: Up to 11 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with biopsy proven B-cell malignancies [e.g. chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), multiple myeloma (MM)]; HIV-associated lymphomas and acute leukemias are not eligible
  • Performance status: ECOG 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Patients with aggressive NHL will be enrolled after having failed all possible therapy with curative intent
  • Patients with CLL must have failed an alkylating agent-containing regimen as well as fludarabine chemotherapy
  • Patients with multiple myeloma must have received at least one prior chemotherapy regimen and not be eligible for a dose intensification treatment approach
  • At least 4 weeks must have elapsed since prior large-field radiation therapy
  • Patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for BCNU and mitomycin C) and recovered from all treatment related toxicity
  • Prior vincristine therapy is allowed
  • Sexually active men and women must use an accepted and effective method of contraception
  • In women of child-bearing age, a pregnancy test may be done at the discretion of the investigator
  • Must have given written informed consent

Exclusion Criteria:

  • Patients with brain metastasis, leptomeningeal involvement, primary CNS NHL, and acute leukemia are ineligible
  • Patients with HIV infection are ineligible
  • WBC < 3000/ul
  • Granulocytes < 1500/ul
  • Platelets < 50,000/ul
  • Hemoglobin =< 8.5 g/dl
  • Bilirubin > 1.5 mg/dl
  • AST and ALT > 2 times normal
  • Creatinine > 2.0 mg/dl, and/or actual creatinine clearance < 40 ml/min/1.73 m^2; all patients are required to have a 24 hr creatinine clearance
  • Clinical evidence of bleeding diathesis
  • ECOG Performance status 3 or 4
  • Patients who are pregnant or lactating; vincristine can cause fetal harm
  • Patients with clinically apparent neuropathy are ineligible (>= grade 2 neuropathy)
Contacts and Locations
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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): NCT00003166


Locations
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United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brenda Cooper Case Western Reserve University
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003166    
Other Study ID Numbers: NCI-2012-03120
CWRU 3Y97
U01CA062502 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2004    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
Lymphoma, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections