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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005950 |
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 506U78 in treating patients who have recurrent or refractory non-Hodgkin's lymphoma or T-cell lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: nelarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of 506U78 (NSC #686673) for Patients With Relapsed or Refractory Indolent B-Cell or Peripheral T-Cell Lymphoma |
Study Start Date: | April 2000 |
OBJECTIVES: I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma when treated with 506U78. II. Assess the pharmacokinetics and toxicity of this treatment in these patients.
OUTLINE: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 51-111 patients will be accrued for this study within 26-37 months.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma Waldenstrom's macroglobulinemia Lymphoplasmacytoid Small lymphocytic Marginal zone Follicular small cleaved cell Follicular mixed cell All peripheral T-cell entities in REAL classification No prior or concurrent evidence of transformation to large cell or follicular large cell lymphoma No B-cell anaplastic large cell lymphoma, cutaneous T-cell lymphoma or any of its variants, and/or histologic transformation of cutaneous T-cell lymphoma Bidimensionally measurable disease No active CNS disease No pericardial effusion
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Unless due to marrow or splenic involvement by lymphoma: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGPT no greater than 2.5 times ULN Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: No history of symptomatic cardiac dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No sensory or motor neuropathy grade 2 or greater No history of seizures No medical, psychiatric, or social condition that would preclude study entry
PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior immunotherapy regimen No prior stem cell or bone marrow transplantation Chemotherapy: No more than 3 prior systemic chemotherapy regimens No prior 506U78 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior anticancer treatment Prior topical treatment or psoralen-ultraviolet-light therapy allowed
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Andre Goy, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000067894, MDA-ID-99208, NCI-430 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005950 |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent adult T-cell leukemia/lymphoma angioimmunoblastic T-cell lymphoma |
recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Chronic lymphocytic leukemia Immunoproliferative Disorders Leukemia, B-cell, chronic Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Lymphoma, T-Cell, Peripheral Recurrence Lymphoma, B-Cell Lymphatic Diseases |
Leukemia Waldenstrom Macroglobulinemia Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Lymphoma, T-Cell Leukemia, T-Cell Waldenstrom macroglobulinemia Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Peripheral T-cell lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |