ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-Cell Lymphoma

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005982
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: nelarabine
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Nelarabine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005982

Locations
United States, Texas
CCOP - M.D. Anderson Research Base    
      Houston, Texas, United States, 77030-4009
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Andre Goy, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067970, MDA-ID-99213, NCI-86
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005982
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cutaneous T-cell non-Hodgkin lymphoma  
recurrent mycosis fungoides/Sezary syndrome  

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Recurrence
Mycoses
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers