Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma

Stopped early · Phase 1

Conditions studied: Recurrent Neuroblastoma

In brief

Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in treating young patients who have refractory or recurrent neuroblastoma. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining interleukin-2 with interleukin-12 may kill more tumor cells.

Key facts

Study ID

NCT00054405

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2002-12-01

Last updated by the study team

2013-04-09

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of neuroblastoma
• Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites
• Persistent and/or refractory disease, with at least 1 of the following:
• Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
• Progressive disease after nonmyeloablative or myeloablative therapy
• Recurrent disease, evidenced by any of the following:
• Biopsy-proven recurrent soft tissue disease
• Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart
• Histologically confirmed bone marrow disease
• Progressive or stable disease after at least 1 prior standard salvage regime
• No clinically significant pleural effusion
• ECOG 0-1
• Life expectancy >= 12 weeks
• Hepatitis A antibody negative
• Hepatitis B surface antigen negative
• Positive hepatitis B titer allowed if patient has been immunized and has no history of disease
• Hepatitis C virus negative
• No history of congenital or acquired coagulation disorder
• Cardiac function normal by ECG
• No dyspnea at rest
• No exercise intolerance
• Oxygen saturation at least 94% by pulse oximetry
• DLCO greater than 60% of predicted
• FEV1 greater than 70% of predicted
• Negative pregnancy test

Where it is running

• New Approaches to Neuroblastoma Treatment (NANT) — Los Angeles, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• University of California at San Francisco - Comprehensive Cancer Center — San Francisco, California, United States
• AFLAC Cancer Center and Blood Disorders Service — Atlanta, Georgia, United States
• Childrens Memorial Hospital — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Michigan University Hospital — Ann Arbor, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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