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| Sponsor: | Beth Israel Deaconess Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003741 |
Purpose
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 |
Biological: 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.
Eligibility| 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
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Study Chair: | Henry Koon, MD | Beth Israel Deaconess Medical Center |
More Information
| Study ID Numbers: | CDR0000066859, BIDMC-97127, NEDH-97127, NCI-870, NCI-V99-1515 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003741 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult Hodgkin lymphoma anaplastic large cell lymphoma |
|
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions Antibodies, Monoclonal Lymphoma, B-Cell Lymphatic Diseases |
Antibodies Neoplasms Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma Immunoglobulins |