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 lymphoma that has not been treated previously or that has not responded to previous treatment.

Condition	Treatment or Intervention	Phase
Leukemia Lymphoma	Drug: U78	Phase II

OBJECTIVES: I. Determine the complete and partial remission rates and remission duration in patients with previously systemically untreated cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population.

PROTOCOL OUTLINE: Patients are stratified according to diagnosis (cutaneous T-cell lymphoma vs peripheral T-cell lymphoma). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to a maximum of 8 courses of therapy. Patients are followed every 3 months for 1 year, and then every 6 months for 1 year or until relapse.

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  up to  69 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically and immunophenotypically confirmed cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) including: Mycosis fungoides/Sezary syndrome; Medium, mixed medium-large, or large cell PTCL; PTCL variants: Angioimmunoblastic T-cell lymphoma; Angiocentric lymphoma; Intestinal T-cell lymphoma; Adult T-cell lymphoma/leukemia; Anaplastic large cell (CD30+) T-cell lymphoma
• Measurable disease Must have measurable skin lesions for CTCL; No barium studies No ascites or pleural effusion; No bony disease; No bone marrow
• No CNS lymphoma requiring intrathecal or craniospinal radiotherapy
• May have failed no more than 2 prior treatment regimens (one may include peripheral blood stem cell transplantation) for PTCL

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; Prior local or topical interferon, monoclonal antibodies, or fusion toxins for CTCL allowed; Recovered from prior biologic therapy
• Chemotherapy: See Disease Characteristics; No prior systemic chemotherapy for CTCL; Prior local or topical chemotherapy for CTCL allowed; Recovered from prior chemotherapy; No other concurrent chemotherapy
• Endocrine therapy: See Disease Characteristics; No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease related conditions (e.g., insulin for diabetes); No concurrent dexamethasone or other steroidal antiemetics
• Radiotherapy: See Disease Characteristics; Prior local radiotherapy or electron beam therapy for CTCL allowed; Recovered from prior radiotherapy
• Surgery: Not specified
• Other: Prior local or topical retinoids for CTCL allowed

--Patient Characteristics--

• Age: Under 70
• Performance status: 0-2
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal
• Renal: Creatinine clearance at least 50 mL/min (unless due to lymphoma)
• Other: HIV negative; No history of seizure disorder; Neurologic toxicity no greater than grade; 1 Not pregnant or nursing; Fertile patients must use effective contraception

Alabama
      Veterans Affairs Medical Center - Birmingham, Birmingham,  Alabama,  35233,  United States
California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Lombardi Cancer Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
      University of Illinois at Chicago Health Sciences Center, Chicago,  Illinois,  60612,  United States
      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Maine
      Veterans Affairs Medical Center - Togus, Togus,  Maine,  04330,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States
      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38103,  United States
      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States
Vermont
      CCOP - Southwestern Vermont Regional Cancer Center, Bennington,  Vermont,  05201,  United States
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      Veterans Affairs Medical Center - Richmond, Richmond,  Virginia,  23249,  United States

Study chairs or principal investigators

Michael W. Schuster,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000067687; CLB-59901; CALGB-59901
Record last reviewed:  April 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005080
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-25