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506U78 in Treating Patients With Lymphoma
This study has been completed.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005080
  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 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)

Resource links provided by NLM:


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

Study Start Date: May 2000
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.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005080

  Show 49 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Myron S. Czuczman, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 03, 2009