Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma

Completed · Phase 2

Conditions studied: 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, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Osteosarcoma, Rhabdomyosarcoma

In brief

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.

Key facts

Study ID

NCT01614795

Run by

National Cancer Institute (NCI)

People needed

46

Starts

2012-06-18

Expected to finish

2014-04-01

Last updated by the study team

2018-12-11

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with any of the following tumors who have experienced relapse following front-line therapy, or who are refractory to front-line therapy, are eligible:
• Osteosarcoma
• Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
• Rhabdomyosarcoma
• Non-rhabdomyosarcoma soft tissue sarcoma
• Patients must have had histologic verification of malignancy at original diagnosis or relapse
• All patients are required to submit archival tumor samples for immunohistochemical analysis (either paraffin-embedded tumor blocks or unstained slides)
• Tissue samples collected at original diagnosis or at relapse or at any subsequent resections or biopsies should be available and ready for shipment to the Biopathology Center (BPC) at time of study enrollment; the samples are required even if tissue samples have previously been sent to the BPC for other purposes or studies; blocks or slides should be shipped to the BPC within 7 days of study enrollment
• Patients must have radiographically measurable disease
• Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
• The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium, or positron emission tomography [PET] scans)
• Elevated tumor markers in plasma or cerebrospinal fluid(CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurements noted above
• Patient?s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• Patients with known central nervous system metastases are excluded unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months
• Patients must have a Lansky or Karnofsky performance status score of ? 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients ? 16 years of age
• Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• For patients with solid tumors without bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) ? 1,000/?L
• Platelet count ? 100,000/?L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
• Hemoglobin ? 8.0 g/dL (may receive red blood cell [RBC] transfusions)

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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