Expired Study
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New York, New York 10065


Purpose:

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. Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.


Criteria:

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 (≥18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S. - The patients are in first CR/VGPR after conventional therapy. They have 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 v3.0) 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


Study is Available At:


Original ID:

09-159


NCT ID:

NCT01183429


Secondary ID:


Study Acronym:


Brief Title:

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neu


Official Title:

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma: A Phase II Study


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Months


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

39


Enrollment Type:

Actual


Overall Contact Information

Official Name:Brian Kushner, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Study Dates

Start Date:August 12, 2010
Completion Date:September 13, 2018
Completion Type:Actual
Primary Completion Date:September 13, 2018
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:July 24, 2019
First Received Date:August 16, 2010
First Results Date:July 24, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Assess the Impact of High-dose 3F8/GM-CSF
Time Frame:2 years
Safety Issues:False
Description:on relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.
Outcome Type:Secondary Outcome
Measure:Apply Real-time Quantitative RT-PCR
Time Frame:2 years
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Monitor Safety of the High-dose Antibody Treatment
Time Frame:2 years
Safety Issues:False
Description:to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.

Study Interventions

Intervention Type:Drug
Name:3F8 and 13-cis-retinoic acid
Description:3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. *High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2.
Arm Name:3F8 and 13-cis-retinoic acid

Study Arms

Study Arm Type:Experimental
Arm Name:3F8 and 13-cis-retinoic acid
Description: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(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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