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| Tracking Information | |||||
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| First Received Date ICMJE | April 6, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005080 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 Lymphoma | ||||
| Official Title ICMJE | 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) | ||||
| 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 lymphoma that has not been treated previously or that has not responded to previous treatment. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: nelarabine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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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: 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 |
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| Gender | Both | ||||
| Ages | up to 69 Years | ||||
| 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 | NCT00005080 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067687, CALGB-59901 | ||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2007 | ||||
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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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