Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00720174 |
RATIONALE: Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody IMC-A12 together with doxorubicin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of monoclonal antibody IMC-A12 given together with doxorubicin and to see how well they work in treating patients with unresectable, locally advanced, or metastatic soft tissue sarcoma.
Condition | Intervention | Phase |
---|---|---|
Adult Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: cixutumumab Drug: doxorubicin hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase ½ Study of Doxorubicin and A12 in Advanced Soft Tissue Sarcoma |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal antibody IMC-A12.
Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour on days 1, 8, and 15 and doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 in the absence of disease progression or unacceptable toxicity.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed soft tissue sarcoma
The following tumor types are not allowed:
PATIENT CHARACTERISTICS:
No poorly controlled diabetes mellitus
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior major surgery, hormonal therapy (other than replacement), or radiotherapy
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153-5500 | |
Contact: Patrick J. Stiff, MD 708-327-3300 | |
Central Illinois Hematology Oncology Center | Recruiting |
Springfield, Illinois, United States, 62701 | |
Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
Decatur Memorial Hospital Cancer Care Institute | Recruiting |
Decatur, Illinois, United States, 62526 | |
Contact: James L. Wade, MD 217-876-6600 | |
Evanston Northwestern Healthcare - Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201-1781 | |
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev 847-570-1381 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
Harvey, Illinois, United States, 60426 | |
Contact: Mark F. Kozloff, MD 708-339-4800 mfkozloff@aol.com | |
Joliet Oncology-Hematology Associates, Limited - West | Recruiting |
Joliet, Illinois, United States, 60435 | |
Contact: Sanjiv S. Modi, MD 815-730-3098 smod@jolietoncology.com | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
Peoria, Illinois, United States, 61615-7828 | |
Contact: Sachdev P. Thomas, MD 309-243-3605 sthomas@ohaci.com | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Everett E. Vokes, MD 773-702-9306 evokes@medicine.bsd.uchicago.edu | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | Recruiting |
South Bend, Indiana, United States, 46601 | |
Contact: David A. Taber, MD 574-647-7370 | |
Fort Wayne Medical Oncology and Hematology | Recruiting |
Fort Wayne, Indiana, United States, 46885-5099 | |
Contact: Sreenivasa R. Nattam, MD 260-484-8830 ledgar@fwmoh.com | |
Howard Community Hospital | Recruiting |
Kokomo, Indiana, United States, 46904-9011 | |
Contact: Naftali Bechar, MD 765-453-8571 naftalibechar@yahoo.com | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
United States, Michigan | |
Oncology Care Associates, PLLC | Recruiting |
Saint Joseph, Michigan, United States, 49085 | |
Contact: Eric P. Lester, MD 269-985-0029 | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109-0640 | |
Contact: Rashmi Chugh, MD 734-936-0453 rashmim@umich.edu | |
United States, Missouri | |
David C. Pratt Cancer Center at St. John's Mercy | Recruiting |
Saint Louis, Missouri, United States, 63141 | |
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J 314-251-6770 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021-6007 | |
Contact: Robert Maki, MD, PhD 212-639-5720 | |
United States, South Carolina | |
Hollings Cancer Center at Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Andrew S. Kraft, MD 843-792-8284 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 |
Principal Investigator: | Rashmi Chugh, MD | University of Michigan Cancer Center |
Study ID Numbers: | CDR0000600157, UCCRC-16227A |
Study First Received: | July 19, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00720174 |
Health Authority: | Unspecified |
recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma adult angiosarcoma childhood angiosarcoma adult desmoplastic small round cell tumor adult epithelioid sarcoma adult extraskeletal chondrosarcoma adult extraskeletal osteosarcoma adult leiomyosarcoma adult liposarcoma adult malignant fibrous histiocytoma of bone adult malignant hemangiopericytoma |
adult malignant mesenchymoma adult neurofibrosarcoma adult rhabdomyosarcoma adult synovial sarcoma dermatofibrosarcoma protuberans mixed childhood rhabdomyosarcoma pleomorphic childhood rhabdomyosarcoma previously treated childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor childhood epithelioid sarcoma childhood fibrosarcoma childhood leiomyosarcoma childhood liposarcoma |
Fibrosarcoma Histiocytoma, Malignant Fibrous Histiocytoma, Benign Fibrous Leiomyosarcoma Malignant mesenchymal tumor Epithelioid sarcoma Osteogenic sarcoma Soft tissue sarcomas Antibodies, Monoclonal Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Dermatofibrosarcoma protuberans Chondrosarcoma Desmoplastic small round cell tumor |
Immunoglobulins Rhabdomyosarcoma Synovial sarcoma Osteosarcoma Hemangiosarcoma Hemangiopericytoma Dermatofibrosarcoma Recurrence Doxorubicin Antibodies Liposarcoma Histiocytoma Sarcoma Malignant fibrous histiocytoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Connective Tissue Antibiotics, Antineoplastic Neoplasms, Fibrous Tissue Pharmacologic Actions |