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Trial record 29 of 163 for:    ISOTRETINOIN

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

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ClinicalTrials.gov Identifier: NCT03033303
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Y-mAbs Therapeutics
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: Hu3F8 Drug: GM-CSF Drug: Isotretinoin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Intervention Model Description: In this phase II single arm trial, patients with HR-NB in first CR or VGPR undergo consolidation by using hu3F8/GM-CSF.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arm Intervention/treatment
Experimental: Hu3F8/GM-CSF Plus Isotretinoin
In 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.
Biological: Hu3F8
Day 1: hu3F8 infused iv over ~30 to 90 minutes. Day 3: hu3F8 infused iv over ~30 to 90 minutes. Day 5: hu3F8 infused iv over ~30 to 90 minutes.

Drug: GM-CSF
Days -4 to 0: GM-CSF 250 mcg/m2/day, subcutaneously. Days 1 to 5: GM-CSF 500 mcg/m2/day, subcutaneously.

Drug: Isotretinoin
Isotretinoin is administered at 160 mg/m2/d, divided into two doses, x14 days.




Primary Outcome Measures :
  1. relapse-free survival (RFS) [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Human anti-hu3F8 antibody (HAHA) titer >1300 Elisa unites/ml

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033303


Contacts
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Contact: Brian H. Kushner, MD 212-639-6793 kushnerb@mskcc.org
Contact: Shakeel Modak, MD 212-639-7623

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Brian H. Kushner, MD    212-639-6793      
Contact: Shakeel Modak, MD    212-639-7623      
Principal Investigator: Brian H. Kushner, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics
Investigators
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Principal Investigator: Brian H. Kushner, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03033303     History of Changes
Other Study ID Numbers: 16-1643
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Hu3F8
GM-CSF
Isotretinoin
16-1643
Additional relevant MeSH terms:
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Isotretinoin
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents