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Bryostatin and Vincristine in B-Cell Malignancies

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Intervention: bryostatin 1 (Drug); vincristine sulfate (Drug); laboratory biomarker analysis (Other)

Phase: Phase 1

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Brenda Cooper, Principal Investigator, Affiliation: Case Western Reserve University

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

Clinical Details

Official title: A Phase I Trial of Combination Bryostatin 1 (NSC 339555) and Vincristine in B-Cell Malignancies

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

MTD

Response rates

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Case Western Reserve University, Cleveland, Ohio 44106, United States
Additional Information

Starting date: May 1998
Last updated: January 10, 2013

Page last updated: August 23, 2015

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