NCT00005579

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1998

Geographic Reach
1 country

4 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

June 1, 1998

Completed
1.9 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
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

June 26, 2013

Status Verified

November 1, 2002

First QC Date

May 2, 2000

Last Update Submit

June 25, 2013

Conditions

LeukemiaLymphoma

Keywords

Waldenström macroglobulinemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphoma

Interventions

dolastatin 10DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologic or cytologic diagnosis of indolent lymphoma as defined by International Working Formulation categories A-C or diagnosis of Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia * Lymphoma must be stage III, IV, or recurrent (no primary CNS lymphoma or lymphomatous meningitis) * Waldenstrom's macroglobulinemia must have at least one of the following: * IGM greater than 3,000 mg/dL * Hemoglobin less than 10.0 g/dL * Bone marrow involvement greater than 30% lymphocytes * At least 2 cm lymphadenopathy * Serum viscosity greater than 3.0 * Chronic lymphocytic leukemia must be intermediate or high risk stages I-IV and have progressed on fludarabine therapy unless patient cannot tolerate fludarabine * Intermediate risk group must have at least one indication of active disease: * Presence of any one of the disease related B symptoms: 10% or more loss of body weight over the preceding 6 month period, extreme fatigue, fever above 100 degrees F without evidence of infection, or night sweats * Massive (greater than 6 cm below left costal margin) or progressive splenomegaly * Massive (greater than 10 cm in longest diameter) or progressive lymphadenopathy * Progressive lymphocytosis with an increase of 50% over a 2 month period or anticipated doubling time of less than 12 months * Evidence of progressive marrow failure as manifested by the development or worsening of anemia and/or thrombocytopenia * Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy * Intolerance, relapse, or failure following prior fludarabine allowed * Measurable or evaluable disease * No untreated immediate life threatening tumor complications PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * CALGB 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * WBC at least 4,000/mm\^3\* * Absolute granulocyte count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* * Hemoglobin at least 9 g/dL\* NOTE: \*Unless documented bone marrow involvement Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Other: * No prior malignancy except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, well differentiated stage IA prostate cancer, or any other cancer from which the patient has been disease free for five years * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior autologous bone marrow or stem cell transplantation Chemotherapy: * See Disease Characteristics * No more than 2 prior systemic regimens for treatment of lymphoma * No chemotherapy for treatment of any other prior malignancy * At least 4 weeks since chemotherapy and recovered * Prior fludarabine therapy allowed Endocrine therapy: * See Disease Characteristics Radiotherapy: * Prior radiotherapy allowed (index lesion cannot be within prior radiotherapy field) Surgery: * Recovered from prior surgery

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

Sponsors & Collaborators

Study Sites (4)

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Non-Hodgkin

Interventions

dolastatin 10

Condition Hierarchy (Ancestors)

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

Study Officials

  • Steven M. Grunberg, MD

    University of Vermont

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

June 1, 1998

Study Completion

February 1, 2003

Last Updated

June 26, 2013

Record last verified: 2002-11

Locations

US(4)