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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00037011 |
Purpose
RATIONALE: Biological therapies such as beta-glucan use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal antibody in treating patients who have metastatic neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: beta-glucan Biological: monoclonal antibody 3F8 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma |
| Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive oral beta-glucan and monoclonal antibody 3F8 (MOAB 3F8) IV within 1.5 hours on days 1-5 and 8-12. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of beta-glucan and MOAB 3F8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3-6 months for 2 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | up to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-risk stage 4 metastatic neuroblastoma
Poor long-term prognosis as defined by any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Nai-Kong V. Cheung, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000069348, MSKCC-01075, NCI-G02-2067 |
| Study First Received: | May 13, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00037011 History of Changes |
| Health Authority: | United States: Federal Government |
|
disseminated neuroblastoma recurrent neuroblastoma |
|
Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Neuroectodermal Tumors, Primitive Immunologic Factors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Recurrence Neuroblastoma Immunoglobulins Neoplasms, Glandular and Epithelial |
|
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions Neuroblastoma Antibodies, Monoclonal |
Neuroectodermal Tumors Neoplasms Antibodies Neoplasms, Germ Cell and Embryonal Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |