Clinical trial NCT00002725: Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Official title: PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-06-23
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jorge E. Romaguera, MD
role: STUDY_CHAIR
References: