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| Tracking Information | |||||
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| First Received Date ICMJE | July 5, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | April 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005950 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-Cell Lymphoma | ||||
| Official Title ICMJE | Phase II Study of 506U78 (NSC #686673) for Patients With Relapsed or Refractory Indolent B-Cell or Peripheral T-Cell Lymphoma | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Drug: nelarabine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005950 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067894, MDA-ID-99208, NCI-430 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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