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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00059995 |
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: monoclonal antibody MDX-060 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma |
Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody 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. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.
Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell or T-cell lymphoma
CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
Must meet one of the following criteria for relapsed/refractory disease:
Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)
Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No apparent opportunistic infection, as indicated by any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Steven M. Horwitz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000298995, MSKCC-02121, MDX-060-01 |
Study First Received: | May 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00059995 |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma anaplastic large cell lymphoma |
recurrent adult diffuse large cell lymphoma recurrent childhood large cell lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Cutaneous T-cell lymphoma Lymphoma, small cleaved-cell, diffuse Recurrence Antibodies, Monoclonal Lymphoma, large-cell Lymphatic Diseases Antibodies |
Hodgkin lymphoma, childhood Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease Immunoglobulins Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |