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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.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005950
  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 non-Hodgkin's lymphoma or 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) for Patients With Relapsed or Refractory Indolent B-Cell or Peripheral T-Cell Lymphoma

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

Study Start Date: April 2000
Detailed Description:

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.

  Eligibility

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005950

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
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: CDR0000067894, MDA-ID-99208, NCI-430
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005950  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent adult T-cell leukemia/lymphoma
angioimmunoblastic T-cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Immunoblastic Lymphadenopathy
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Lymphoma, T-Cell, Peripheral
Recurrence
Lymphoma, B-Cell
Lymphatic Diseases
Leukemia
Waldenstrom Macroglobulinemia
Leukemia, Lymphocytic, Chronic, B-Cell
B-cell lymphomas
Lymphoma, T-Cell
Leukemia, T-Cell
Waldenstrom macroglobulinemia
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Peripheral T-cell lymphoma
Follicular lymphoma

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

ClinicalTrials.gov processed this record on January 16, 2009