Clinical Trial: NCT02100930 - My Cancer Genome

NCT02100930

Description:

The purpose of this study is to be able to supply an experimental combination of drugs called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may benefit from treatment.

Related Conditions:

Neuroblastoma

Recruiting Status:

Completed

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02100930

Trial Eligibility

Document

Title

Brief Title: Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma
Official Title: Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

Clinical Trial IDs

ORG STUDY ID: 13-260
NCT ID: NCT02100930

Conditions

Neuroblastoma

Interventions

Drug	Synonyms	Arms
Anti-GD2 3F8 Monoclonal Antibody		Neuroblastoma
GM-CSF (granulocyte-macrophage colony-stimulating factor)		Neuroblastoma
oral isotretinoin		Neuroblastoma

Purpose

Detailed Description

      This treatment uses 3F8/GM-CSF and isotretinoin for: Group 1 patients are in 1st CR/VGPR;
      Group 2 patients are in a ≥2nd CR/VGPR; and Group 3 patients have primary refractory NB in
      BM. All patients will receive 3F8/GM-CSF through 24 months.

      Road Map/Schema for Group 1 (1st CR/VGPR) and Group 2 (≥2nd CR/VGPR) patients:

      Cycle 1 3F8 (iv) + GM-CSF subcutaneous (sc) (1 wk) 2-4-wk interval Cycle 2 3F8 (iv) + GM-CSF
      (sc) (1 wk) 2-4-wk interval* - oral isotretinoin x14 days Cycle 3 3F8 (iv) + GM-CSF (sc) (1
      wk) 2-4-wk interval - oral isotretinoin x14 days Cycle 4 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk
      interval - oral isotretinoin x14 days on, 14 days off, 14 days on Cycle 5 3F8 (iv) + GM-CSF
      (sc) (1 wk) 6-8-wk interval - oral isotretinoin x14 days on, 14 days off, 14 days on (6th
      cycle) Cycle 6 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval Cycle 7 3F8 (iv) + GM-CSF (sc)
      (1 wk) Continue with 6-8-wk intervals through 24 months from 1st dose of 3F8. * assessment of
      BM status by standard histology

      Road Map/Schema for Group 3 patients (BM positive): The break between end of a cycle of
      3F8/GM-CSF and start of next cycle is approximately 2-to-4-weeks through 4 cycles after
      achievement of CR in BM; subsequent breaks are ~6-8 weeks. Please see roadmap below for a
      patient achieving CR in BM after cycle 1. Cycle 1 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk
      interval* - BM negative Cycle 2 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval* - oral
      isotretinoin x14 days Cycle 3 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral
      isotretinoin x14 days Cycle 4 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral
      isotretinoin x14 days Cycle 5 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral
      isotretinoin x14 days Cycle 6 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral
      isotretinoin x14 days on, 14 days off, 14 days on (6th cycle) Cycle 7 3F8 (iv) + GM-CSF (sc)
      (1 wk) 6-8-wk interval Continue with 6-8-wk intervals through 24 months from 1st dose of 3F8.

      * assessment of BM response by standard histology

Trial Arms

Name	Type	Description	Interventions
Neuroblastoma	Experimental	This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients.	Anti-GD2 3F8 Monoclonal Antibody GM-CSF (granulocyte-macrophage colony-stimulating factor) oral isotretinoin

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of NB as defined by international criteria,62 i.e., histopathology
             (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine
             catecholamine levels.

          -  High-risk NB, as defined by risk-related treatment guidelines and the International NB
             Staging System, i.e., stage 4 with (any age) or without (>18 months)
             MYCNamplification, 63 or MYCN-amplified NB other than stage 1.64,65

          -  Patients are in CR/VGPR or have primary refractory NB in BM - i.e., NB resistant to
             standard therapy, as evidenced by persistence of NB in BM by histology or MIBG scan,
             but all other findings in scans show VGPR.

          -  Children and adults are eligible.

          -  Signed informed consent indicating awareness of the scheduling and side effects, as
             well as testing requirements, of this program.

        Exclusion Criteria:

          -  Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic,
             pulmonary, or gastrointestinal toxicity > or = to grade 3, except for grade 3
             hematologic toxicity.

          -  Progressive disease (PD)

          -  History of allergy to mouse proteins.

          -  Active life-threatening infection.

          -  Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

          -  Pregnant women

          -  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:	Therapeutic Response
Time Frame:	2 years
Safety Issue:
Description:	Disease status is defined by the International Neuroblastoma Response Criteria - Complete response/remission (CR): NED; Partial response/remission: >50% decrease in all disease parameters, exceptbone scan unchanged or improved; no more than 1 positive bone marrow site; Stable disease: <50% decrease in all tumor markers; Progressive disease (PD): new lesion, or >25 % increase in any disease marker.

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Memorial Sloan Kettering Cancer Center

Trial Keywords

Anti-GD2 3F8 Monoclonal Antibody
oral isotretinoin
GM-CSF
Sargramostim
13-260

Last Updated

February 28, 2020

Clinical Trials /

Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma