506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma

Study Overview
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Brief Summary
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Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma

Detailed Description
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PRIMARY OBJECTIVES: I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78. II. Determine the toxicity of this drug in these patients. III. 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.

Official Title
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Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

Conditions
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Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome

Intervention / Treatment
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* Drug: nelarabine
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma Large cell transformation of cutaneous T-cell lymphoma allowed No active CNS disease Performance status - Zubrod 0-2 Absolute neutrophil count at least 1,000/mm^3* Platelet count at least 100,000/mm^3* Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGPT no greater than 2.5 times ULN Creatinine clearance greater than 50 mL/min No history of symptomatic cardiac dysfunction No history of pericardial effusion 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 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 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 At least 3 weeks since prior anticancer endocrine therapy No concurrent topical or systemic steroids 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 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

Ages Eligible for Study
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Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (nelarabine)<br>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. | Drug: nelarabine<br>* Given IV<br>* Other names: GW506U78;Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RR) defined as CR + PR rates |  | Up to 4 years |