Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma

Titre officiel

A Phase II Study of Temsirolimus (CCI-779, NSC 683864) and IGF-1 Receptor Antibody IMC-A12 (NSC 742460) in Patients With Metastatic Sarcomas

Sommaire:

Le temsirolimus pourrait stopper la multiplication des cellules tumorales en inhibant certaines des enzymes indispensables à la croissance cellulaire. Les anticorps monoclonaux, comme le cixutumumab, peuvent stopper la croissance tumorale de différentes façons. Certains empêchent les cellules cancéreuses de croître et de se propager. D’autres localisent les cellules cancéreuses et aident à les tuer ou transportent vers elles des substances antitumorales. L’administration du temsirolimus avec du cixutumumab pourrait permettre de tuer un plus grand nombre de cellules tumorales.

Cet essai de phase II vise à évaluer l’efficacité du temsirolimus associé au cixutumumab dans le traitement de patients atteints d’un sarcome des tissus mous ou d’un ostéosarcome localement avancé, métastatique ou récidivant.

Description de l'essai

OBJECTIVES:

Primary

• To determine the progression-free survival rate at 12 weeks in patients with locally advanced, metastatic, or recurrent IGF1R-positive soft tissue sarcoma, IGF1R-positive bone sarcoma, or IGF1R-negative sarcoma treated with cixutumumab and temsirolimus.

Secondary

• To determine the overall response rate (complete and partial response) in these patients.
• To determine the overall survival of these patients.
• To determine the correlation between clinical outcome and pre- and post-treatment IGF1R pathway-related markers in plasma, archived tissue, and tumour biopsy samples.

OUTLINE: This is a multicentre study. Patients are stratified according to IGF1-receptor status and disease (IGF1R-positive soft tissue sarcoma vs IGF1R-positive bone sarcoma vs IGF1R-negative sarcoma).

Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and tissue sample collection periodically for correlative studies.

After completion of study treatment, patients are followed up for ≥ 4 weeks.

Reviewed by OCREB

Voir cet essai sur ClinicalTrials.gov