High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma
This study is currently recruiting participants.
Verified July 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01183429
First received: August 16, 2010
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to see if high-dose 3F8 is better than standard dose 3F8 in treating neuroblastoma.
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. The investigators now wish to see if using a higher dose of 3F8 will be better than standard dose 3F8 in killing neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: 3F8 and 13-cis-retinoic acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | High-Dose 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 |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Assess the impact of high-dose 3F8/GM-CSF [ Time Frame: 2 years ] [ Designated as safety issue: No ]on relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.
Secondary Outcome Measures:
- Apply real-time quantitative RT-PCR [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Monitor safety of the high-dose antibody treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.
| Estimated Enrollment: | 58 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 3F8 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. 13-cis-retinoic acid is started after cycle 2.
|
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. It is not taken on same days as 3F8.
|
Eligibility| Ages Eligible for Study: | 18 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 (> or = to 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183429
Contacts
| Contact: Brian Kushner, MD | 212-639-6793 | |
| Contact: Nai-Kong Cheung, MD, Ph.D | 646-888-2313 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Brian Kushner, MD 212-639-6793 | |
| Contact: Nai-Kong Cheung, MD, PhD 646-888-2313 | |
| Principal Investigator: Brian Kushner, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Brian Kushner, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01183429 History of Changes |
| Other Study ID Numbers: | 09-159 |
| Study First Received: | August 16, 2010 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
MAB 3F8 RETINOIC ACID (CIS-9 & 13) Bone Marrow 09-159 |
Additional relevant MeSH terms:
|
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 Isotretinoin Tretinoin Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Keratolytic Agents |
ClinicalTrials.gov processed this record on October 17, 2012
