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 cutaneous T-cell lymphoma.

Condition	Treatment or Intervention	Phase
recurrent cutaneous T-cell lymphoma recurrent mycosis fungoides/Sezary syndrome	Drug: 506U78  Procedure: chemotherapy	Phase II

OBJECTIVES:

• Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.
• Determine the toxicity of this drug in these patients
• Study the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
• Large cell transformation of cutaneous T-cell lymphoma allowed
• No active CNS disease

PATIENT CHARACTERISTICS: Age:

• 16 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3*
• Platelet count at least 100,000/mm^3* NOTE: *Unless attributable to marrow or splenic involvement by lymphoma

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
• No history of pericardial effusion

Other:

• HIV negative
• No grade 2 or greater sensory or motor neuropathy
• No history of seizures
• No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
• No medical, psychiatric, or social condition that would preclude study
• No other concurrent serious illness or active infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior stem cell or bone marrow transplantation (BMT)
• No more than 1 prior immunotherapy regimen
• No more than 3 prior systemic regimens with denileukin diftitox
• At least 3 weeks since prior biologic therapy
• No concurrent BMT

Chemotherapy:

• No prior 506U78
• No more than 3 prior systemic chemotherapy regimens comprising any of the following:
• Oral methotrexate
• Topical mechlorethamine
• At least 3 weeks since prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• At least 3 weeks since prior anticancer endocrine therapy
• No concurrent topical or systemic steroids

Radiotherapy:

• At least 3 weeks since prior radiotherapy
• No more than 3 prior systemic regimens comprising any of the following:
• Total skin electron beam therapy
• Spot radiotherapy

Surgery:

• Not specified

Other:

• No more than 3 prior systemic regimens comprising any of the following:
• Oral retinoids
• Ultraviolet therapy (PUVA)
• At least 3 weeks since prior anticancer therapy

Texas
      CCOP - M.D. Anderson Research Base, Houston,  Texas,  77030-4009,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Andre Goy, MD,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067970; MDA-ID-99213; NCI-86
Record last reviewed:  March 2003
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005982
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22