Clinical Trial: Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
recurrent small lymphocytic lymphoma
recurrent adult diffuse large cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
 Drug: bryostatin 1
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bryostatin 1 in Relapsed non-Hodgkin's Lymphoma

Further Study Details: 

Study start: August 1996

OBJECTIVES: I. Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma.

II. Assess the toxic effects of this treatment.

III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes.

IV. Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics.

PROTOCOL OUTLINE: Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.

PROJECTED ACCRUAL: In each stratum, a total of 35 patients will be entered over 1 year if there are at least 2 responses in the first 12 patients.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • See Disease Characteristics; At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered

--Patient Characteristics--

  • Age: Any age
  • Performance status: Zubrod 0-2
  • Life expectancy: Greater than 12 weeks
  • Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.8 mg/dL; Transaminases no greater than 2.5 times normal
  • Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min
  • Other: No HIV antibody; No serious intercurrent illness; No pregnant or nursing women; Effective contraception required of fertile patients throughout study and for 1 year thereafter

Location Information


Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Jorge Enrique Romaguera,  Study Chair,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064591; MDA-DM-95061; NCI-T95-0035D
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002725
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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