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High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma

This study is currently recruiting participants.
Verified January 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01183884
First received: August 16, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes

August 16, 2010
January 31, 2013
August 2010
August 2014   (final data collection date for primary outcome measure)
Assess the impact of high-dose 3F8/GM-CSF on relapse-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.
Same as current
Complete list of historical versions of study NCT01183884 on ClinicalTrials.gov Archive Site
  • Apply real-time quantitative RT-PCR to test the hypothesis that the minimal residual disease content of bone marrow [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.
  • Monitor safety of the high-dose antibody treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.
Same as current
Not Provided
Not Provided
 
High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma: A Phase II Study

The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what effects, good and/or bad, 3F8 has on the cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that could be left in the bone marrow.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuroblastoma
Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid

3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. The patients are in > or = to 2nd CR/VGPR and at high risk for additional relapse.

Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started after cycle 2.
Experimental: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess relapse-free survival in patients who are in second or greater complete/very good partial remission (CR/VGPR) but are at very high risk of another relapse of their neuroblastoma.
Intervention: Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
63
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
  • High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
  • The patients are in >2nd CR/VGPR, including no measurable MIBG-avid soft tissue tumor assessable for response.
  • Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

  • Creatinine > 3.0 mg/dL
  • ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal
  • Bilirubin > 3.0 mg/dL
  • Patients with grade 3 or higher toxicities (using the CTCAE v34.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
  • Progressive disease
  • History of allergy to mouse proteins
  • Active life-threatening infection.
  • Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.
  • Inability to comply with protocol requirements.
Both
18 Months and older
No
Contact: Brian Kushner, MD 212-639-6793
Contact: Nai-Kong Cheung, MD, PhD 646-888-2313
United States
 
NCT01183884
09-160
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Brian Kushner, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP