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Clinical Trials (PDQ®)

  • First Published: 8/1/1998
  • Last Modified: 1/13/2003

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Clinical Trials (PDQ®)

Phase II Study of Dolastatin 10 in Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 and overNCIVCC-9802
NCI-T98-0007, NCT00005579, T98-0007

Objectives

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

Entry Criteria

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

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

Patient Characteristics:

Age:

  • 18 and over

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • WBC at least 4,000/mm3*
  • Absolute granulocyte count at least 1,500/mm3*
  • Platelet count at least 100,000/mm3*
  • 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Vermont Cancer Center at University of Vermont

Steven Grunberg, MD, Protocol chair
Ph: 802-656-5457
Email: steven.grunberg@uvm.edu

Registry Information
Official Title Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia
Trial Start Date 1998-06-17
Registered in ClinicalTrials.gov NCT00005579
Date Submitted to PDQ 1998-06-11
Information Last Verified 2002-11-21
NCI Grant/Contract Number CA22435

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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