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CompletedNCT00003166Updated Jan 11, 2013

Bryostatin and Vincristine in B-Cell Malignancies

A Phase 1 interventional study of bryostatin 1 and vincristine sulfate in Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Adult Diffuse Mixed Cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-11.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • 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
03

In context

Burkitt Lymphoma

391 studies on the registry are indexed under Burkitt Lymphoma; 113 are open to participants now.

This study's planned enrollment of 18 is below the median of 41 across 353 interventional studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,505 studies on the registry; 333 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • 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 · Drug: vincristine sulfate · Other: laboratory biomarker analysis

Interventions

  • Drugbryostatin 1

    Given IV

    Also known as: B705008K112, BRYO, Bryostatin

  • Drugvincristine sulfate

    Given IV

    Also known as: leurocristine sulfate, VCR, Vincasar PFS

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. MTD

    Time frame: 2 weeks

  2. Response rates

    Time frame: Up to 11 years

07

Study locations

1 site
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003166
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 19, 2004
Start date
May 1998
Primary completion
Jul 2001
Last update
Jan 11, 2013

Study contacts

Brenda Cooper
principal investigator · Case Western Reserve University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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