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

Summary

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.

Conditions

• 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

Interventions

BIOLOGICAL

Cixutumumab

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Rashmi Chugh · University of Chicago Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2013-01-31

Countries

• United States

Study Locations