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Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma


Phase 1
N/A
49 Years
Not Enrolling
Both
Neuroblastoma

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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 CenterNew York, New York  10021