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Sponsors and Collaborators: |
Stanford University National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006009 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.
Condition | Intervention | Phase |
Lymphoma Small Intestine Cancer |
Drug: monoclonal antibody HuM291 |
Phase I |
MedlinePlus related topics: | Cancer Fungal Infections Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
ChemIDplus related topics: | Visilizumab |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-Cell Lymphomas |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 1 month and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 12-15 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 CD3+ T-cell lymphoma for which no standard curative therapy exists
Peripheral T-cell lymphoma
Mycosis fungoides
Stage IB/IIA
Stage IIB-IVB
All other T-cell lymphomas
Evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |||||
Stanford University Medical Center | |||||
Stanford, California, United States, 94305-5408 |
Stanford University |
National Cancer Institute (NCI) |
Study Chair: | Youn H. Kim, MD | Stanford University |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068017, SUMC-NCI-102, NCI-102 |
First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006009 |
Health Authority: | United States: Federal Government |
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