Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate to the combination of cixutumumab and temsirolimus in patients with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcoma.

II. To further describe the toxicities (including dose-limiting toxicities) of cixutumumab and temsirolimus administered on this schedule.

SECONDARY OBJECTIVES:

I. To assess the progression-free survival for patients treated in each disease stratum with this drug combination.

II. To assess the incidence of insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) pathway activation in archival tumor material, and correlate with response.

III. To evaluate minimal residual disease and IGF-1R tumor cell expression in the blood and bone marrow of Ewing sarcoma patients using flow cytometry.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (osteosarcoma vs Ewing sarcoma/PNET vs rhabdomyosarcoma vs non-rhabdomyosarcoma soft tissue sarcoma).

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples from most recent biopsy are collected and analyzed for IGF-1R, insulin receptor, AKT, ERK, mTOR, and S6 kinase pathway activation by immunohistochemistry (IHC) and banked for future correlative studies. Blood and bone marrow samples, from patients with Ewing sarcoma, may be collected at baseline and periodically during treatment for minimal residual disease analysis by flow cytometry.

After completion of study treatment, patients are followed up periodically for 5 years. ;


Study Design


Related Conditions & MeSH terms

  • Childhood Alveolar Soft Part Sarcoma
  • Childhood Angiosarcoma
  • Childhood Epithelioid Sarcoma
  • Childhood Fibrosarcoma
  • Childhood Gliosarcoma
  • Childhood Leiomyosarcoma
  • Childhood Liposarcoma
  • Childhood Malignant Peripheral Nerve Sheath Tumor
  • Childhood Synovial Sarcoma
  • Fibrosarcoma
  • Gliosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Neoplasms
  • Nerve Sheath Neoplasms
  • Neurilemmoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Osteosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma, Ewing
  • Sarcoma, Synovial

NCT number NCT01614795
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date June 18, 2012
Completion date April 1, 2014

See also
  Status Clinical Trial Phase
Recruiting NCT04388839 - Evolutionary Therapy for Rhabdomyosarcoma Phase 2
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Completed NCT01674101 - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy N/A
Completed NCT00520936 - A Study of Pemetrexed in Children With Recurrent Cancer Phase 2
Completed NCT03655587 - Impact of an Orthotic Intervention in Children With Peripheral Neuropathy N/A
Recruiting NCT06094101 - Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision) Phase 1/Phase 2
Recruiting NCT04625907 - FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma Phase 1/Phase 2
Active, not recruiting NCT04095221 - A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma Phase 1/Phase 2
Completed NCT01661400 - Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors Phase 1
Recruiting NCT04337177 - Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors Phase 1
Active, not recruiting NCT02945800 - Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma Phase 2
Not yet recruiting NCT06029465 - Analyzing Engagement Trends in Rhabdomyosarcoma Clinical Trials
Terminated NCT02536183 - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Phase 1
Recruiting NCT00592592 - Proton RT for the Treatment of Pediatric Rhabdomyosarcoma Phase 2
Completed NCT00187174 - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors Phase 1
Completed NCT01505569 - Auto Transplant for High Risk or Relapsed Solid or CNS Tumors N/A
Active, not recruiting NCT03220035 - Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT05093322 - A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors Phase 1/Phase 2
Completed NCT04956198 - Drug Sensitivity and Mutation Profiling
Recruiting NCT04791228 - A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors Phase 2