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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nelarabine
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (nelarabine)

Arm 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.

Outcomes

Primary Outcome Measures

Response rate (RR) defined as CR + PR rates

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005982
Brief Title
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Official Title
Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
April 2000 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (nelarabine)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
nelarabine
Other Intervention Name(s)
506U78, Arranon, GW506U78
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (RR) defined as CR + PR rates
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Goy
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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