NCT00087425

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Bryostatin 1 may help rituximab kill more cancer cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_2 leukemia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

April 30, 2015

Status Verified

January 1, 2007

Enrollment Period

3.3 years

First QC Date

July 8, 2004

Last Update Submit

April 29, 2015

Conditions

LeukemiaLymphoma

Keywords

contiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomacontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomarecurrent grade 1 follicular lymphomastage III grade 1 follicular lymphomastage IV grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomarecurrent grade 2 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 2 follicular lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomarefractory chronic lymphocytic leukemiaWaldenström macroglobulinemiacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (2)

  • Feasability and safety

  • Antitumor response

Secondary Outcomes (3)

  • Functional and molecular status of effector cells

  • Expression of CD20 and complement-inhibitory molecules on tumor cells before and after treatment

  • Effects on global gene expression pattern in chronic lymphocytic leukemia cells

Interventions

rituximabBIOLOGICAL
bryostatin 1DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * One of the following histologically or cytologically confirmed diseases: * Indolent B-cell non-Hodgkin's lymphoma (NHL) * Stage II-IV disease * Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria: * Intermediate-risk with progressive disease * High-risk, modified Rai stage disease * CD20-positive by flow cytometry or immunohistochemistry * Measurable disease * Rituximab-refractory disease, defined as failure to achieve a response to the last course of prior treatment with rituximab alone or in combination with other therapeutic modalities * No known neoplastic leptomeningeal involvement and/or brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 50,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal (unless due to Gilbert's disease or organ involvement by NHL or CLL) Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to murine protein * Prior infusion reactions to rituximab without an IgE component allowed * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Radiotherapy * At least 12 weeks since prior rituximab * More than 4 weeks since prior immunotherapy and recovered Chemotherapy * No more than 3 prior chemotherapy regimens * More than 4 weeks since prior chemotherapy and recovered Endocrine therapy * No concurrent glucocorticoids Radiotherapy * At least 12 weeks since prior radioimmunotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * At least 4 weeks since prior therapy for the malignancy * No other concurrent anticancer therapy * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (1)

NIH - Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLymphoma, Non-HodgkinLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom Macroglobulinemia

Interventions

Rituximabbryostatin 1

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Igor Espinoza-Delgado, MD

    Gerontology Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

July 1, 2004

Primary Completion

October 1, 2007

Last Updated

April 30, 2015

Record last verified: 2007-01

Locations

US(1)