Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

Completed · Phase 2

Conditions studied: Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Childhood Hepatoblastoma, Childhood Synovial Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adrenocortical Carcinoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive, Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Retinoblastoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors

In brief

This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. 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.

Key facts

Study ID

NCT00831844

Run by

National Cancer Institute (NCI)

People needed

116

Starts

2009-01-01

Expected to finish

2013-10-01

Last updated by the study team

2015-03-30

Who can join

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

You may qualify if…

• Histologically confirmed malignant solid tumor, including the following:
• Osteosarcoma
• Ewing sarcoma/peripheral primitive neuroectodermal tumor
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms tumor
• Synovial sarcoma
• Hepatoblastoma
• Adrenocortical carcinoma
• Retinoblastoma
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
• Radiographically measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan
• The following are not considered measurable disease:
• Ascites, pleural effusions, or other malignant fluid collections
• Bone marrow infiltration by tumor
• Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan)
• Previously irradiated lesions that have not demonstrated clear progression post-radiotherapy
• No known Central Nervous System (CNS) metastases unless they were treated by surgery or radiotherapy AND are stable with no recurrent lesions for ≥ 3 months
• Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology Group (ECOG) PS 0-2
• Absolute neutrophil count (ANC) ≥ 1,000/mm³ (> 250/mm³ for patients with neuroblastoma)
• Platelet count ≥ 75,000/mm³ (> 25,000/mm³ for patients with neuroblastoma) (transfusion independent)
• Hemoglobin ≥ 8.0 g/dL (≥ 7.5 g/dL for patients with neuroblastoma) (RBC transfusion allowed)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine normal based on age/gender as follows:
• ≤ 0.4 mg/dL (for patients 1 to 5 months of age)
• ≤ 0.5 mg/dL (for patients 6 to 11 months of age)

Where it is running

• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — 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
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Nemours Childrens Clinic - Orlando — Orlando, Florida, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Saint Joseph Children's Hospital of Tampa — Tampa, Florida, United States
• Saint Mary's Hospital — West Palm Beach, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Saint Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• University of Illinois — Chicago, Illinois, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Saint Jude Midwest Affiliate — Peoria, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States

Full record on ClinicalTrials.gov

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