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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 cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3F8 monoclonal antibody and 13-cis-Retinoic Acid | Experimental | 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. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3F8 monoclonal antibody and 13-cis-Retinoic Acid | Drug | A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival | in patients who are post-stem-cell transplantation and in first complete or very good partial remission, but at high risk of relapse. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow | after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival. | 2 years |
| Monitor Safety of the High-dose Antibody Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kushner, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23633099 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3F8 Monoclonal Antibody and 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. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse. 3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2012 |
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|
to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study. |
| 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3F8 Monoclonal Antibody and 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. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse. 3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival | in patients who are post-stem-cell transplantation and in first complete or very good partial remission, but at high risk of relapse. | Data were not collected | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow | after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival. | Data were not collected | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | Monitor Safety of the High-dose Antibody Treatment | to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study. | Data were not collected | Posted | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3F8 Monoclonal Antibody and 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. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse. 3F8 monoclonal antibody and 13-cis-Retinoic Acid: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2. | 2 | 4 | 1 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Vacular disorders - Other | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Resp, thoracic & mediastinal disorder Other | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Skin & subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Kushner, MD | Memorial Sloan Kettering Cancer Center | 212-639-6793 | kushnerb@mskcc.org |
| Sep 16, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|