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506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-Cell Lymphoma
This study has been completed.
Study NCT00005950   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
April 2000
 
 
 
Complete list of historical versions of study NCT00005950 on ClinicalTrials.gov Archive Site
 
 
 
506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-Cell Lymphoma
Phase II Study of 506U78 (NSC #686673) for Patients With Relapsed or Refractory Indolent B-Cell or Peripheral 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 non-Hodgkin's lymphoma or T-cell lymphoma.

OBJECTIVES: I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma when treated with 506U78. II. Assess the pharmacokinetics and toxicity of this treatment in these patients.

OUTLINE: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 51-111 patients will be accrued for this study within 26-37 months.

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: Diagnosis of recurrent or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma Waldenstrom's macroglobulinemia Lymphoplasmacytoid Small lymphocytic Marginal zone Follicular small cleaved cell Follicular mixed cell All peripheral T-cell entities in REAL classification No prior or concurrent evidence of transformation to large cell or follicular large cell lymphoma No B-cell anaplastic large cell lymphoma, cutaneous T-cell lymphoma or any of its variants, and/or histologic transformation of cutaneous T-cell lymphoma Bidimensionally measurable disease No active CNS disease No pericardial effusion

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Unless due to marrow or splenic involvement by lymphoma: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 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 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No sensory or motor neuropathy grade 2 or greater No history of seizures No medical, psychiatric, or social condition that would preclude study entry

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior immunotherapy regimen No prior stem cell or bone marrow transplantation Chemotherapy: No more than 3 prior systemic chemotherapy regimens No prior 506U78 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior anticancer treatment Prior topical treatment or psoralen-ultraviolet-light therapy allowed

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005950
 
CDR0000067894, MDA-ID-99208, NCI-430
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Andre Goy, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
May 2005

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