Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia

June 25, 2013 updated by: University of Vermont

Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Estimate the efficacy of dolastatin 10 in patients with indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.
  • Evaluate the qualitative and quantitative toxicities of dolastatin 10 in this patient population.
  • Investigate the mechanism of action of dolastatin 10 in regards to apoptosis and effects of microtubules.

OUTLINE: This is an open-label, multicenter study. Patients are stratified by disease (chronic lymphocytic leukemia vs indolent lymphoma vs Waldenstrom's macroglobulinemia).

All patients receive dolastatin 10 IV bolus every 3 weeks. Patients continue treatment until disease progression, unacceptable toxicity, or patient's withdrawal from the study.

PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study over 15 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Vermont
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Steven M. Grunberg, MD, University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion

December 7, 2022

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

November 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCC-9802
  • CDR0000066360 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-T98-0007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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