Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
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
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.
Inclusion Criteria:
Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
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:
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:
No more than 3 prior systemic regimens comprising any of the following:
At least 3 weeks since prior anticancer therapy