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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003741 |
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: monoclonal antibody HeFi-1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study |
Study Start Date: | February 1999 |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study.
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.
Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Study Chair: | Henry Koon, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000066859, BIDMC-97127, NEDH-97127, NCI-870, NCI-V99-1515 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003741 |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma anaplastic large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Recurrence Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases Antibodies |
B-cell lymphomas Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Anaplastic large cell lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Hodgkin Disease Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |