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

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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)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: bryostatin 1 Drug: chemotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
Study Start Date : August 1996
Actual Primary Completion Date : April 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
 Drug: bryostatin 1
Drug: chemotherapy


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002725


Locations
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United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: Jorge E. Romaguera, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002725    
Other Study ID Numbers: NCI-2012-02239
MDA-DM-95061
NCI-T95-0035D
CDR0000064591 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 23, 2004    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: October 2000
Keywords provided by National Cancer Institute (NCI):
recurrent small lymphocytic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
 recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents