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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005982
First received: July 5, 2000
Last updated: January 22, 2013
Last verified: January 2013

July 5, 2000
January 22, 2013
April 2000
July 2004   (final data collection date for primary outcome measure)
Response rate (RR) defined as CR + PR rates [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00005982 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Drug: nelarabine
    Given IV
    Other Names:
    • 506U78
    • Arranon
    • GW506U78
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
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.
Interventions:
  • Drug: nelarabine
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
Not Provided
July 2004   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005982
NCI-2012-02344, ID99-213, CDR0000067970
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Andre Goy M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP