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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00071825 |
Purpose
This study will determine how much MEDI-507 can be safely given to people with lymphoproliferative diseases - certain cancers that affect infection-fighting white blood cells called T cells. In most cancers that affect T cells, the cells have a protein on their surface called CD2. MEDI-507 is a genetically engineered antibody that targets CD2. In laboratory studies, MEDI-507 has shown some effect in animals with T-cell cancer.
Patients 18 years of age and older with adult T-cell leukemia/lymphoma, cutaneous T-cell lymphoma, peripheral T-cell lymphoma, or large granular lymphocyte leukemia who have CD2 protein on their T cells may be eligible for this study. Patients (except for those with adult T-cell leukemia/lymphoma) must have had prior treatment with chemotherapy, radiation therapy, or antibodies. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, x-rays and other imaging studies, photographs of skin lesions, if any, a skin biopsy (removal of a small piece of tissue) of suspicious lesions, and lymph node biopsy, if the node is accessible by a fine needle.
Patients are enrolled into one of seven groups, with three patients per group. Subsequent groups of patients receive a higher dose of MEDI-507 than the previous one as long as the drug continues to be safe and well tolerated. The first group of patients receives 0.2 milligrams mg/kg of the drug for 2 consecutive days every other week for 16 weeks. The next three patients entering the study receive the same dose for 3 consecutive days every other week. Subsequent groups receive higher doses of the antibody. Patients are hospitalized on the days they receive the antibody.
In addition to MEDI-507 treatment, patients may receive additional therapies as follows:
After patients complete the 16-week course of treatment, they return to the clinic for follow-up examinations 30 days after the last drug dose and then every 3 months for 1 year.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoproliferative Disorders |
Drug: MEDI-507 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Medi-507 in CD2-Positive Lymphoproliferative Disease |
| Enrollment: | 29 |
| Study Start Date: | October 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Background:
Objectives:
Eligibility:
-Patients with CD2 positive lymphoproliferative disease including untreated patients with adult T-cell leukemia/lymphoma; patients with large granular lymphocyte leukemia, peripheral T-cell lymphoma and cutaneous T-cell lymphoma who have progressive disease after standard therapy.
Design:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients must meet all of the following criteria at the time of enrollment.
Histologically confirmed diagnosis of a lymphoproliferative disorder as determined by the Laboratory of Pathology at the Clinical Center at the National Institutes of Health (NIH). Only patients with the following lymphoproliferative disorders will be eligible.
EXCLUSION CRITERIA:
Patients must have none of the following at the time of enrollment.
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00071825 History of Changes |
| Obsolete Identifiers: | NCT00075361 |
| Other Study ID Numbers: | 040031, 04-C-0031 |
| Study First Received: | October 31, 2003 |
| Last Updated: | December 30, 2011 |
| Health Authority: | United States: Federal Government |
|
Mycosis Fungoides Adult T-Cell Lymphoma Peripheral Lymphoma |
Monoclonal Antibody Large Granular Lymphocyte Lymphoproliferative Disease |
|
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |