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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005579
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: dolastatin 10 Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia
Study Start Date : June 1998
Actual Study Completion Date : February 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified


  • 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


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • 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


Biologic therapy:

  • No prior autologous bone marrow or stem cell transplantation


  • 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


  • Prior radiotherapy allowed (index lesion cannot be within prior radiotherapy field)


  • Recovered from prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005579

United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Sponsors and Collaborators
University of Vermont
National Cancer Institute (NCI)
Study Chair: Steven M. Grunberg, MD University of Vermont Identifier: NCT00005579     History of Changes
Other Study ID Numbers: VCC-9802
CDR0000066360 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: November 2002

Keywords provided by National Cancer Institute (NCI):
Waldenström macroglobulinemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Dolastatin 10
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action