Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
N/A
49 Years
Both
Neuroblastoma
Trial Information
Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
OBJECTIVES:
- Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in
patients with metastatic neuroblastoma.
- Determine the toxicity of this regimen in these patients.
- Assess the biological effects of this regimen in these patients.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed high-risk stage 4 metastatic neuroblastoma
- May be confirmed by bone marrow involvement and elevated urinary catecholamines
- Progressive or persistent disease after intensive conventional chemotherapy that
included induction with N6, N7, N8, or COG protocol with or without bone marrow or
stem cell transplantation
- Poor long-term prognosis as defined by any of the following:
- N-myc amplification in tumor cells
- Diploid chromosomal content plus 1p loss of heterozygosity in tumor cells
- Distant skeletal metastases
- Unresectable primary tumor infiltrating across the midline
- More than 10% tumor cells in bone marrow
- Measurable or evaluable disease documented at least 4 weeks after completion of prior
systemic therapy
PATIENT CHARACTERISTICS:
Age:
- Under 50
Performance status:
- Not specified
Life expectancy:
- See Disease Characteristics
Hematopoietic:
- Platelet count greater than 25,000/mm^3
- Absolute neutrophil count greater than 500/mm^3
Hepatic:
- Not specified
Renal:
- Creatinine clearance greater than 60 mL/min
Other:
- No severe major organ toxicity
- No active life-threatening infections
- No prior allergy to mouse proteins
- No prior allergy to beta-glucan, oats, barley, mushrooms, or yeast
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior exposure to mouse antibodies and human anti-mouse antibody greater than
1,000 ELISA units/mL
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent supplemental beta-glucan either as food (e.g., bran cereals) or
as complementary medicine
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Nai-Kong V. Cheung, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
01-075
NCT ID:
NCT00037011
Start Date:
November 2001
Completion Date:
Related Keywords:
- Neuroblastoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- Neuroblastoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
