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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To collect safety data about the combination of doxorubicin and Cixitumumab and determine if they can be combined with acceptable toxicity at full doses.

SECONDARY OBJECTIVES:

I. To assess the confirmed response rate (CR + PR as defined by RECIST) of patients with locally advanced or metastatic soft tissue sarcoma when treated with combination doxorubicin and Cixitumumab II. To assess the 3 and 6 month progression free survival rate of patients treated with doxorubicin and Cixitumumab.

III. To assess the progression free survival and overall survival of patients treated with doxorubicin and Cixitumumab.

IV. To evaluate changes in left ventricular ejection fraction assessed by MUGA scan after 2, 4 and 6 cycles of therapy compared to baseline.

OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal antibody cixutumumab.

Patients receive cixutumumab intravenously (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 cixutumumab in the absence of disease progression or unacceptable toxicity. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • 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
  • Chondrosarcoma
  • Dermatofibrosarcoma
  • Dermatofibrosarcoma Protuberans
  • Desmoplastic Small Round Cell Tumor
  • Fibrosarcoma
  • Hemangiopericytoma
  • Histiocytoma, Malignant Fibrous
  • Leiomyosarcoma
  • Liposarcoma
  • Liver Neoplasms
  • Malignant Adult Hemangiopericytoma
  • Malignant Childhood Hemangiopericytoma
  • Metastatic Childhood Soft Tissue Sarcoma
  • Nerve Sheath Neoplasms
  • Neurilemmoma
  • Neurofibroma
  • Osteosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Synovial
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Untreated Childhood Rhabdomyosarcoma

NCT number NCT00720174
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date June 2008

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