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506U78 in Treating Patients With Lymphoma
This study has been completed.
Study NCT00005080   Information provided by National Cancer Institute (NCI)
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes

April 6, 2000
July 23, 2008
May 2000
 
 
 
Complete list of historical versions of study NCT00005080 on ClinicalTrials.gov Archive Site
 
 
 
506U78 in Treating Patients With Lymphoma
A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-Cell Lymphoma (CTCL) or With Refractory or Relapsed Non-Cutaneous Peripheral T-Cell Lymphoma (PTCL)

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 lymphoma that has not been treated previously or that has not responded to previous treatment.

OBJECTIVES: I. Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population.

OUTLINE: Patients are stratified according to diagnosis (cutaneous T-cell lymphoma vs peripheral T-cell lymphoma). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy. Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse.

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.

Phase II
Interventional
Treatment
  • Lymphoma
  • Small Intestine Cancer
Drug: nelarabine
 
Czuczman MS, Porcu P, Johnson J, Niedzwiecki D, Kelly M, Hsi ED, Cook JR, Canellos G, Cheson BD; Cancer and Leukemia Group B. Results of a phase II study of 506U78 in cutaneous T-cell lymphoma and peripheral T-cell lymphoma: CALGB 59901. Leuk Lymphoma. 2007 Jan;48(1):97-103.

*   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 and immunophenotypically confirmed cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) including: Mycosis fungoides/Sezary syndrome Medium, mixed medium-large, or large cell PTCL PTCL variants: Angioimmunoblastic T-cell lymphoma Angiocentric lymphoma Intestinal T-cell lymphoma Adult T-cell lymphoma/leukemia Anaplastic large cell (CD30+) T-cell lymphoma Measurable disease Must have measurable skin lesions for CTCL The following are not considered measurable: Barium studies Ascites or pleural effusion Bony disease Bone marrow No CNS lymphoma requiring intrathecal or craniospinal radiotherapy May have failed no more than 2 prior treatment regimens (one may include peripheral blood stem cell transplantation) for PTCL

PATIENT CHARACTERISTICS: Age: Under 70 Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine clearance at least 50 mL/min (unless due to lymphoma) Other: HIV negative No history of seizure disorder Neurologic toxicity no greater than grade 1 Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior local or topical interferon, monoclonal antibodies, or fusion toxins for CTCL allowed Recovered from prior biologic therapy Chemotherapy: See Disease Characteristics No more than 1 prior course of single-agent systemic chemotherapy for CTCL No prior multiagent systemic chemotherapy Prior local or topical chemotherapy for CTCL allowed Recovered from prior chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: See Disease Characteristics Prior local radiotherapy or electron beam therapy for CTCL allowed Recovered from prior radiotherapy Surgery: Not specified Other: Prior local or topical retinoids for CTCL allowed

Both
up to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005080
 
CDR0000067687, CALGB-59901
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Myron S. Czuczman, MD Roswell Park Cancer Institute
National Cancer Institute (NCI)
March 2007

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