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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002725
Recruitment Status : Completed
First Posted : June 23, 2004
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE June 23, 2004
Last Update Posted Date February 5, 2013
Study Start Date  ICMJE August 1996
Actual Primary Completion Date April 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Official Title  ICMJE PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
Brief Summary Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed Description

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.

OUTLINE:

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: bryostatin 1
  • Drug: chemotherapy
Study Arms  ICMJE Experimental: Arm I
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
Interventions:
  • Drug: bryostatin 1
  • Drug: chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February¬†4,¬†2013)
35
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma
  • Working formulation low-, intermediate-, and high-grade histologies eligible
  • Mantle cell and marginal zone lymphoma eligible
  • Relapse after at least 1 doxorubicin-containing regimen required
  • No more than 2 prior chemotherapy regimens
  • One prior biologic therapy in addition to the 2 prior chemotherapy regimens allowed
  • No prior bone marrow transplantation
  • Ineligible for treatment on higher priority protocols
  • Patients eligible for bone marrow transplantation may be treated to reduce tumor bulk
  • Bidimensionally measurable disease required
  • No history of primary or metastatic CNS disease

PATIENT CHARACTERISTICS:

  • Age: Any age
  • Performance status: Zubrod 0-2
  • Life expectancy: Greater than 12 weeks
  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 100,000/mm3
  • Bilirubin no greater than 1.8 mg/dL
  • Transaminases no greater than 2.5 times normal
  • Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 70 mL/min
  • 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

PRIOR CONCURRENT THERAPY:

-At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002725
Other Study ID Numbers  ICMJE NCI-2012-02239
MDA-DM-95061
NCI-T95-0035D
CDR0000064591 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jorge E. Romaguera, MD M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date October 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP