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

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ClinicalTrials.gov Identifier: NCT00005982
Recruitment Status : Terminated (Administratively complete.)
First Posted : January 27, 2003
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 2000
Actual Primary Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Nelarabine

Arms and Interventions
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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 Name: pharmacological studies


Outcome Measures
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Primary Outcome Measures :
  1. Response rate (RR) defined as CR + PR rates [ Time Frame: Up to 4 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005982


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andre Goy M.D. Anderson Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005982    
Other Study ID Numbers: NCI-2012-02344
ID99-213
CDR0000067970 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Recurrence
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Lymphoma, Non-Hodgkin
Bacterial Infections and Mycoses
Infections