NCT00005580

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

3 active sites

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

September 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

7.9 years

First QC Date

May 2, 2000

Last Update Submit

February 23, 2010

Conditions

LeukemiaLymphoma

Keywords

recurrent cutaneous T-cell non-Hodgkin lymphomaWaldenstrom macroglobulinemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiaB-cell chronic lymphocytic leukemiarefractory hairy cell leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult T-cell leukemia/lymphomaprolymphocytic leukemiarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

bryostatin 1DRUG
fludarabine phosphateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed chronic lymphocytic leukemia * Stage I (symptomatic or with bulky lymphadenopathy) * Stage II, III, or IV * Prior chemotherapy allowed, including fludarabine or other purine nucleoside analog therapy OR * Histologically confirmed indolent non-Hodgkin's lymphoma * Progressive or relapsed following chemotherapy * Includes the following histologies: * B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas * Lymphoplasmacytoid lymphoma (Waldenstrom's)/immunocytoma * Mantle cell lymphoma * Follicular lymphoma * Small cell * Mixed small and large cell * Diffuse (predominately small cell type) * Marginal zone B-cell lymphoma * Extranodal (MALT-type with or without monocytoid B-cells) * Provisional subtype: nodal (with or without monocytoid B-cells) * Provisional entity: splenic marginal zone lymphoma (with or without villous lymphocytes) * Hairy cell leukemia * Peripheral T-cell and NK-cell neoplasms * T-cell chronic lymphocytic leukemia/polylymphocytic leukemia * Large granular lymphocyte leukemia * T-cell type * NK-cell type * Mycosis fungoides/Sezary's syndrome (cutaneous T-cell lymphoma) * No CNS disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,000/mm3 * Platelet count at least 75,000/mm3 * Hemoglobin at least 8 g/dL * Coombs negative Hepatic: * AST/ALT no greater than 2.5 times upper limit of normal * Bilirubin no greater than 2 mg/mL Renal: * Creatinine clearance at least 40 mL/min Other: * No concurrent neurologic condition * No other concurrent medical condition that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent systemic immunoglobulin therapy * No prior bone marrow or peripheral stem cell transplantation Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior systemic chemotherapy Endocrine therapy: * No concurrent systemic glucocorticoid therapy Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (3)

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Related Publications (1)

  • Roberts JD, Smith MR, Feldman EJ, Cragg L, Millenson MM, Roboz GJ, Honeycutt C, Thune R, Padavic-Shaller K, Carter WH, Ramakrishnan V, Murgo AJ, Grant S. Phase I study of bryostatin 1 and fludarabine in patients with chronic lymphocytic leukemia and indolent (non-Hodgkin's) lymphoma. Clin Cancer Res. 2006 Oct 1;12(19):5809-16. doi: 10.1158/1078-0432.CCR-05-2730.

    PMID: 17020988RESULT

MeSH Terms

Conditions

LeukemiaLymphomaLymphoma, T-Cell, CutaneousWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Large Granular LymphocyticLeukemia, Hairy CellLymphoma, FollicularLymphoma, Non-HodgkinPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal Zone

Interventions

bryostatin 1fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell

Study Officials

  • Steven Grant, MD

    Massey Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

September 1, 1998

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

US(3)