Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00037011 |
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 |
Drug: beta-glucan Drug: 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.
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:
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 |
Study ID Numbers: | CDR0000069348, MSKCC-01075, NCI-G02-2067 |
Study First Received: | May 13, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00037011 |
Health Authority: | United States: Federal Government |
disseminated neuroblastoma recurrent neuroblastoma |
Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Neuroectodermal Tumors, Primitive, Peripheral Recurrence Neuroblastoma Immunoglobulins Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |