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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00005982

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome	Drug: nelarabine Other: pharmacological study	Phase 2

Detailed Description

PRIMARY 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. 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (nelarabine) 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 Given IV Other Names: 506U78 Arranon GW506U78 Other: pharmacological study Correlative studies Other Names: pharmacological studies

Arm

Intervention/Treatment

Experimental: Treatment (nelarabine)

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

Given IV

Other Names:

506U78

Arranon

GW506U78

Other: pharmacological study

Correlative studies

Other Names:

pharmacological studies

Outcome Measures

Primary Outcome Measures

Response rate (RR) defined as CR + PR rates [Up to 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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