Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005080 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Small Intestine Cancer |
Drug: nelarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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) |
Study Start Date: | May 2000 |
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.
Ages Eligible for Study: | up to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study Chair: | Myron S. Czuczman, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000067687, CALGB-59901 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005080 History of Changes |
Health Authority: | United States: Federal Government |
stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma recurrent adult T-cell leukemia/lymphoma |
angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
Gastrointestinal Diseases Sezary Syndrome Mycosis Fungoides Ileal Diseases Lymphoma, T-Cell, Peripheral Lymphoma, Small Cleaved-cell, Diffuse Duodenal Neoplasms Leukemia Mycoses Ileal Neoplasms Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-cell Lymphoma |
Duodenal Diseases Jejunal Neoplasms Peripheral T-cell Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy Intestinal Diseases Recurrence Intestinal Neoplasms Lymphatic Diseases Digestive System Diseases Leukemia, T-Cell Gastrointestinal Neoplasms |
Jejunal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Gastrointestinal Diseases Intestinal Diseases Ileal Diseases Lymphoma, T-Cell, Peripheral Intestinal Neoplasms Duodenal Neoplasms Lymphatic Diseases |
Neoplasms Digestive System Diseases Neoplasms by Site Ileal Neoplasms Jejunal Diseases Lymphoma, T-Cell Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Duodenal Diseases Lymphoma, T-Cell, Cutaneous |