Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

Recruiting in Palo Alto (17 mi)

+104 other locations

Overseen byBrenda Weigel, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Brenda Weigel, MD

Principal Investigator

Children's Oncology Group

Eligibility Criteria

Inclusion Criteria

Osteosarcoma

Ewing sarcoma/peripheral primitive neuroectodermal tumor Rhabdomyosarcoma

Neuroblastoma

See 7 more

Treatment Details

Interventions

Cixutumumab (Monoclonal Antibodies)

Participant Groups

10Treatment groups

Experimental Treatment

Group I: Grp 7-Neuroblastoma with measurable diseaseExperimental Treatment2 Interventions

Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group II: Grp 6 - Neuroblastoma-MIBG Positive Without Measurable DiseaseExperimental Treatment2 Interventions

Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group III: Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorExperimental Treatment2 Interventions

Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group IV: Grp 4-Recurrent or Refractory Adrenocortical CarcinomaExperimental Treatment2 Interventions

Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group V: Group 9 - Recurrent or Refractory Wilms TumorExperimental Treatment2 Interventions

Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group VI: Group 8 - Recurrent OsteosarcomaExperimental Treatment2 Interventions

Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group VII: Group 3 - Recurrent or Refractory RhabdomyosarcomaExperimental Treatment2 Interventions

Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group VIII: Group 2 - Recurrent or Refractory Synovial SarcomaExperimental Treatment2 Interventions

Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group IX: Group 10 - Recurrent or Refractory RetinoblastomaExperimental Treatment2 Interventions

Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Group X: Group 1 - Recurrent or Refractory HepatoblastomaExperimental Treatment2 Interventions

Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.