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Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
This study has been completed.
First Received: May 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Vermont
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005579
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Drug: dolastatin 10
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Dolastatin 10
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005579

Locations
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
Investigators
Study Chair: Steven M. Grunberg, MD University of Vermont
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066360, VCC-9802, NCI-T98-0007
Study First Received: May 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005579     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom 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

Study placed in the following topic categories:
Leukemia, Lymphoid
Blood Protein Disorders
Lymphoma, Follicular
Paraproteinemias
Hemostatic Disorders
Follicular Lymphoma
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Hemorrhagic Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoma
Dolastatin 10
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Antimitotic Agents
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Chronic Lymphocytic Leukemia
Tubulin Modulators
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell

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

ClinicalTrials.gov processed this record on May 07, 2009