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

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 2

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

Treatments: Other: pharmacological study; Drug: nelarabine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00005982

ID99-213

NCI-2012-02344

CDR0000067970 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Treatment (nelarabine)

Experimental group

Description:

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.

Treatment:

Other: pharmacological study

Drug: nelarabine