Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors (NCT00831844) | Clinical Trial Compass
CompletedPhase 2
Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
United States116 participantsStarted 2009-01
Plain-language summary
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.
Who can participate
Age range7 Months – 30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 clearanc…