Study Stopped
Administratively complete.
Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
4 other identifiers
interventional
40
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 5, 2003
CompletedFirst Posted
Study publicly available on registry
February 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedApril 9, 2013
April 1, 2013
6.4 years
February 5, 2003
April 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
28 days
Secondary Outcomes (1)
Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Up to 3 weeks
Study Arms (1)
Treatment (IL-12, aldesleukin)
EXPERIMENTALCohort A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12. Cohort B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A. Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator. Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD.
Interventions
Given IV
Given IV
Eligibility Criteria
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
- +60 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
New Approaches to Neuroblastoma Treatment (NANT)
Los Angeles, California, 90027-6016, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
University of California at San Francisco - Comprehensive Cancer Center
San Francisco, California, 94143-0875, United States
AFLAC Cancer Center and Blood Disorders Service
Atlanta, Georgia, 30322, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
University of Michigan University Hospital
Ann Arbor, Michigan, 48109, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Wigginton
New Approaches to Neuroblastoma Treatment (NANT)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2003
First Posted
February 6, 2003
Study Start
December 1, 2002
Primary Completion
May 1, 2009
Last Updated
April 9, 2013
Record last verified: 2013-04