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506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-Cell Lymphoma
This study has been completed.
Study NCT00005982   Information provided by National Cancer Institute (NCI)
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes

July 5, 2000
July 23, 2008
October 2000
 
 
 
Complete list of historical versions of study NCT00005982 on ClinicalTrials.gov Archive Site
 
 
 
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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma.

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
  • 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.

Phase II
Interventional
Treatment
Lymphoma
Drug: nelarabine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma

    • Large cell transformation of cutaneous T-cell lymphoma allowed
  • No active CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3*
  • Platelet count at least 100,000/mm^3* NOTE: *Unless attributable to marrow or splenic involvement by lymphoma

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGPT no greater than 2.5 times ULN

Renal:

  • Creatinine clearance greater than 50 mL/min

Cardiovascular

  • No history of symptomatic cardiac dysfunction
  • No history of pericardial effusion

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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

Chemotherapy:

  • 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

Endocrine therapy:

  • At least 3 weeks since prior anticancer endocrine therapy
  • No concurrent topical or systemic steroids

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • 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
 
CDR0000067970, MDA-ID-99213, NCI-86
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Andre Goy, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
September 2002

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