Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 16 and over NCI MDA-ID-99213 NCI-86, NCT00005982, 86

Objectives

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

Entry 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

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

Patient Characteristics:

Age:

• 16 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm³*
• Platelet count at least 100,000/mm³*

 [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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Andre Goy, MD, Protocol chair(Contact information may not be current)		Ph: 713-792-6161; 800-392-1611

Registry Information
Official Title		Phase II Study of 506U78 (NSC #686673) in Patients with Previously Treated Cutaneous T-Cell Lymphoma
Trial Start Date		2000-10-06
Registered in ClinicalTrials.gov		NCT00005982
Date Submitted to PDQ		2000-05-11
Information Last Verified		2002-09-30
NCI Grant/Contract Number		P30-CA16672

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