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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dolastatin 10
Sponsored by
University of Vermont
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Barbara Ann Karmanos Cancer Institute
  • Arthur G. James Cancer Hospital - Ohio State University
  • Vermont Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 25, 2013
Sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005579
Brief Title
Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
Official Title
Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dolastatin 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Grunberg, MD
Organizational Affiliation
University of Vermont
Official's Role
Study Chair
Facility Information:
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States

12. IPD Sharing Statement

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

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