NCT00002725

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

June 23, 2004

Completed
Last Updated

February 5, 2013

Status Verified

October 1, 2000

Enrollment Period

3.7 years

First QC Date

November 1, 1999

Last Update Submit

February 4, 2013

Conditions

Lymphoma

Keywords

recurrent small lymphocytic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

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

Drug: bryostatin 1Drug: chemotherapy

Interventions

bryostatin 1DRUG
Arm I
chemotherapyDRUG
Arm I

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

bryostatin 1Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jorge E. Romaguera, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 23, 2004

Study Start

August 1, 1996

Primary Completion

April 1, 2000

Last Updated

February 5, 2013

Record last verified: 2000-10

Locations

US(1)