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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052403 |
Purpose
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 solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: monoclonal antibody anti-anb3 integrin Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: growth factor antagonist therapy Procedure: monoclonal antibody therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated as above at that dose level.
PROJECTED ACCRUAL: A total of 27-33 patients will be accrued for this study within 9-11 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Study Chair: | Patricia LoRusso, DO | Harper Hospital |
More Information
| Study ID Numbers: | CDR0000258300, WSU-C-2453, NCI-5496 |
| Study First Received: | January 24, 2003 |
| Last Updated: | January 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00052403 History of Changes |
| Health Authority: | United States: Federal Government |
|
Antibodies, Monoclonal Antibodies Molecular Mechanisms of Pharmacological Action Immunologic Factors Mitosis Modulators |
Physiological Effects of Drugs Mitogens Pharmacologic Actions Immunoglobulins |