|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006228 |
Purpose
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill breast cancer cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: aldesleukin Biological: trastuzumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial of Anti-Her2 Monoclonal Antibody Trastuzumab (Herceptin) in Combination With Low Dose Interleukin-2 (Proleukin) in Metastatic Breast Cancer Patients Who Have Previously Failed Trastuzumab |
| Study Start Date: | January 2001 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1 and 8 and interleukin-2 subcutaneously (SC) on days 2-7 and 9-21. Beginning on day 22, patients receive trastuzumab IV over 30 minutes every 14 days. Patients also receive interleukin-2 SC daily on days 1-14. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
Unidimensionally measurable disease
The following are not considered measurable:
CNS metastases allowed if all of the following conditions are met:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
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, Illinois | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Michigan | |
| Lakeland Medical Center - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth Medical School | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| United States, Tennessee | |
| East Tennessee State University Cancer Center at JCMC | |
| Johnson City, Tennessee, United States, 37604 | |
| Study Chair: | Charles L. Shapiro, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Study ID Numbers: | CDR0000068150, OSU-99H0192, OSU-9945, NCI-195 |
| Study First Received: | September 11, 2000 |
| Last Updated: | July 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006228 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer male breast cancer |
|
Anti-Infective Agents Anti-HIV Agents Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Aldesleukin |
Anti-Retroviral Agents Sensory System Agents Interleukin-2 Analgesics, Non-Narcotic Therapeutic Uses Trastuzumab Peripheral Nervous System Agents Analgesics Central Nervous System Agents Breast Diseases |