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A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

NCT03033303

Description:

The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03033303

Trial Eligibility

Document

Title

  • Brief Title: A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma
  • Official Title: Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study

Clinical Trial IDs

  • ORG STUDY ID: 16-1643
  • NCT ID: NCT03033303

Conditions

  • Neuroblastoma

Interventions

DrugSynonymsArms
Hu3F8Hu3F8/GM-CSF Plus Isotretinoin
GM-CSFHu3F8/GM-CSF Plus Isotretinoin
IsotretinoinHu3F8/GM-CSF Plus Isotretinoin

Purpose

The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.

Trial Arms

NameTypeDescriptionInterventions
Hu3F8/GM-CSF Plus IsotretinoinExperimentalIn this phase II single arm trial, patients with HR-NB in first CR or VGPR undergo consolidation by using hu3F8/GM-CSF x5 cycles and isotretinoin x6 cycles. Isotretinoin starts after cycle 2 of hu3F8/GM-CSF.
  • Hu3F8
  • GM-CSF
  • Isotretinoin

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of
             Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
             levels.

          -  Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and
             MYCN-nonamplified stage 4 in patients greater than 18 months of age).

          -  Patients must be in first CR/VGPR

          -  Patients must have a negative human anti-hu3F8 antibody (HAHA) titer

        Exclusion Criteria:

          -  Existing major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic,
             pulmonary, or gastrointestinal toxicity ≥ grade 3, with the exception of hearing loss
             and hematologic toxicity.

          -  Active life-threatening infection.

          -  Inability to comply with protocol requirements
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:relapse-free survival (RFS)
Time Frame:2 years
Safety Issue:
Description:Patients are considered a response failure under this protocol if progressive disease is evident before two years. Deaths from toxicity attributable to protocol treatment will be counted as events. Patients who withdraw or are lost to followup before two years will be considered as progressions.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Hu3F8
  • GM-CSF
  • Isotretinoin
  • 16-1643

Last Updated

December 11, 2020