Cixutumumab and Doxorubicin Hydrochloride in Treating Patients With Unresectable, Locally Advanced, or Metastatic Soft Tissue Sarcoma

Completed · Phase 1

Conditions studied: Adult Angiosarcoma, Adult Desmoplastic Small Round Cell Tumor, Adult Epithelioid Sarcoma, Adult Extraskeletal Myxoid Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Mesenchymoma, Adult Malignant Peripheral Nerve Sheath Tumor, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Adult Undifferentiated High Grade Pleomorphic Sarcoma of Bone, Childhood Angiosarcoma, Childhood Desmoplastic Small Round Cell Tumor, Childhood Epithelioid Sarcoma, Childhood Fibrosarcoma, Childhood Leiomyosarcoma, Childhood Liposarcoma, Childhood Malignant Mesenchymoma, Childhood Malignant Peripheral Nerve Sheath Tumor, Childhood Pleomorphic Rhabdomyosarcoma, Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features, Childhood Synovial Sarcoma, Dermatofibrosarcoma Protuberans, Malignant Adult Hemangiopericytoma, Malignant Childhood Hemangiopericytoma, Metastatic Childhood Soft Tissue Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Untreated Childhood Rhabdomyosarcoma

In brief

This phase I trial is studying the side effects and best dose of cixutumumab given together with doxorubicin hydrochloride and to see how well they work in treating patients with unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies, such as cixutumumab, 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 hydrochloride, 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 cixutumumab together with doxorubicin hydrochloride may kill more tumor cells.

Key facts

Study ID

NCT00720174

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2008-06-01

Last updated by the study team

2016-05-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed soft tissue sarcoma
• Unresectable disease
• Locally advanced or metastatic disease
• The following tumor types are not allowed:
• Embryonal and alveolar rhabdomyosarcoma
• Gastrointestinal stromal tumor
• Alveolar soft part sarcoma
• Clear cell sarcoma
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• No more than 1 prior therapy for sarcoma
• No known brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• ANC ≥ 1,500/µL
• Platelet count ≥ 100,000/µL
• Leukocytes ≥ 3,000/µL
• Total bilirubin ≤ upper limit of normal(ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fasting serum glucose < 120 mg/dL OR below ULN
• LVEF ≥ 50% by MUGA scan
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after the last dose of anti-IGF-1R recombinant monoclonal antibody IMC-A12
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12
• No poorly controlled diabetes mellitus

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mercy Hospital Saint Louis — St Louis, Missouri, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.