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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01183884
First received: August 16, 2010
Last updated: October 15, 2014
Last verified: October 2014

August 16, 2010
October 15, 2014
August 2010
August 2015   (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
 
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
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 find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.

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 .Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage.

Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles. The patients are in > or = to 2nd CR/VGPR and at high risk for additional relapse. 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, open-label, single arm trial assesses the anti-NB activity of high-dose 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. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
Intervention: Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
Kushner BH, Modak S, Basu EM, Roberts SS, Kramer K, Cheung NK. Posterior reversible encephalopathy syndrome in neuroblastoma patients receiving anti-GD2 3F8 monoclonal antibody. Cancer. 2013 Aug 1;119(15):2789-95. doi: 10.1002/cncr.28137. Epub 2013 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
August 2015
August 2015   (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 information is only displayed when the study is recruiting subjects
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
October 2014

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