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 States, Australia, Canada116 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 range
7 Months – 30 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.