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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Drug: dolastatin 10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dolastatin 10|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, 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