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	Treatment or Intervention	Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma recurrent adult T-cell leukemia/lymphoma angioimmunoblastic T-cell lymphoma small intestine lymphoma Waldenstrom's Macroglobulinemia recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma	Drug: U78	Phase II

Further Study Details: 

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.

PROTOCOL OUTLINE: Patients receive 506U78 IV over 120 minutes on days 1, 3, and 5. Treatment continues every 28 days for a maximum of 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.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• Biologic therapy: No more than 1 prior immunotherapy regimen; No prior stem cell or bone marrow transplant
• Chemotherapy: No more than 2 prior chemotherapy regimens (3 if one was chemoimmunotherapy); No prior 506U78
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified
• Other: At least 3 weeks since prior anticancer treatment

--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
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No other prior malignancy in past 5 years except adequately 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

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Andreas H. Sarris,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067894; MDA-ID-99208; NCI-430
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005950
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08