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
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
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.
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 →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.
Exclusion Criteria:
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
Given IV
Also known as: B705008K112, BRYO, Bryostatin
Given IV
Also known as: leurocristine sulfate, VCR, Vincasar PFS
Correlative studies
MTD
Time frame: 2 weeks
Response rates
Time frame: Up to 11 years
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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National Cancer Institute (NCI)