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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075361 |
Purpose
RATIONALE: Monoclonal antibodies such as siplizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of siplizumab in treating patients with lymphoproliferative disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: siplizumab |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase I Trial Of Medi-507 In CD2-Positive Lymphoproliferative Disease |
| Estimated Enrollment: | 88 |
| Study Start Date: | November 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive siplizumab (MEDI-507) IV over 4 hours on days 1 and 2 every 2 weeks for 16 weeks OR on days 1-3 every 2 weeks for 16 weeks OR on days 1 and 14, then weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients with a positive treatment response (e.g., stable disease, minor response, partial response, or complete response) after 16 weeks of treatment may continue to receive MEDI-507 as above in the absence of disease progression or unaccebtable toxicity.
Cohorts of 3-6 patients receive escalating doses of MEDI-507 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of treatment, patients are followed at 30 days and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed lymphoproliferative disorder, including the following types:
Adult T-cell leukemia
Cutaneous T-cell lymphoma
Peripheral T-cell lymphoma
Large granular lymphocyte leukemia meeting the following criteria:
Must have 1 of the following:
Myelosuppression based on at least 1 of the following laboratory values:
CD2-positive by immunohistochemistry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | John E. Janik, MD | NCI - Metabolism Branch;MET |
More Information
| Study ID Numbers: | CDR0000344422, NCI-04-C-0031, MEDIMMUNE-MI-CP094 |
| Study First Received: | January 9, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075361 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent cutaneous T-cell non-Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome recurrent adult T-cell leukemia/lymphoma |
stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma T-cell large granular lymphocyte leukemia stage IV cutaneous T-cell non-Hodgkin lymphoma stage IV mycosis fungoides/Sezary syndrome anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma |
|
Lymphatic Diseases Leukemia Neoplasms Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Lymphoproliferative Disorders Lymphoma |