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

Neuroblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183429
• Other study ID #: 09-159
• Status: Completed
• Phase: Phase 2
• Start date: August 12, 2010
• Est. completion date: September 13, 2018

Study information

• Verified date: April 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 13, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• 3F8 and 13-cis-retinoic acid
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Impact of High-dose 3F8/GM-CSF	on relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.	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.	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center