Protocol Number: 04-C-0031

Title:

Phase I Trial of Medi-507 in CD2-Positive Lymphoproliferative Disease

Number:

04-C-0031

Summary:

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:

- Diphenhydramine (Benadryl® (Registered Trademark)) and acetominophen (Tylenol® (Registered Trademark)) to reduce allergic reactions to MEDI-507.

- Blood transfusions to maintain sufficient levels of blood cells and platelets.

- Filgrastim, a drug that stimulates production of white blood cells, to improve white cell counts.

- Allopurinol, a drug that helps help prevent tumor lysis syndrome. Cancer treatment may sometimes result in this condition, which upsets the way the body gets rid of certain chemicals in the blood. Allopurinol is taken by mouth for 5 days starting 1 day before each MEDI-507 infusion.

- Anti-infective agents, such as fluconazole, valacyclovir, trimethoprim-sulfamethoxazole, and others as needed to prevent bacterial, viral, or fungal infections.

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Mycosis Fungoides

Adult T-Cell Lymphoma

Peripheral Lymphoma

Monoclonal Antibody

Large Granular Lymphocyte

Lymphoproliferative Disease

Recruitment Keyword(s):

None

Condition(s):

Lymphoproliferative Disorders

Investigational Drug(s):

MEDI-507

Investigational Device(s):

None

Interventions:

Drug: MEDI-507

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Catane R, Longo DL. Monoclonal antibodies for cancer therapy. Isr J Med Sci. 1988 Sep-Oct;24(9-10):471-6.

Grillo-Lopez AJ, White CA, Varns C, Shen D, Wei A, McClure A, Dallaire BK. Overview of the clinical development of rituximab: first monoclonal antibody approved for the treatment of lymphoma. Semin Oncol. 1999 Oct;26(5 Suppl 14):66-73.

Shak S. Overview of the trastuzumab (Herceptin) anti-HER2 monoclonal antibody clinical program in HER2-overexpressing metastatic breast cancer. Herceptin Multinational Investigator Study Group. Semin Oncol. 1999 Aug;26(4 Suppl 12):71-7.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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