Rhabdomyosarcoma Clinical Trial
Official title:
A Phase II Study of Cixutumumab (IMC-A12) in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors
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.
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.
;
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 |