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PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jorge E. Romaguera, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02239

NCT ID:

NCT00002725

Start Date:

August 1996

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009