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

Phase 1
Open (Enrolling)

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Trial Information

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



- Determine the clinical toxicity of beta-glucan in combination with monoclonal antibody
3F8 in patients with metastatic neuroblastoma.

- Evaluate the biologic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study of beta-glucan.

Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV
over 30-90 minutes on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 4 courses
in the absence of disease progression or unacceptable toxicity and with a human antimouse
antibody (HAMA) titer < 1,000 U/mL.

Cohorts of 3-6 patients receive escalating doses of beta-glucan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.

Patients undergo urine, bone marrow, and blood sample collection periodically for biological
studies. Samples are analyzed for antibody-dependent cellular cytotoxicity,
complement-mediated cytotoxicity, and serum HAMA response via immunohistochemistry.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


- Diagnosis of neuroblastoma by 1 of the following methods:

- Histopathology

- Bone marrow involvement AND elevated urinary catecholamines

- High-risk disease, defined by 1 of the following:

- Stage 4 disease with MYCN amplification (any age) or without MYCN amplification
(> 18 months of age)

- MYCN-amplified stage 3 disease (unresectable and any age)

- MYCN-amplified stage 4S disease

- Metastatic disease

- Tumor progression or persistent disease (at metastatic or primary site) after
intensive conventional chemotherapy

- Must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive
MIBG or PET scans) or measurable (CT scan or MRI) disease documented after completion
of prior systemic therapy


- Platelet count > 25,000/mm^3

- ANC > 500/mm^3

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of allergy to mouse proteins, beta-glucan, mushrooms, or yeast

- No active life-threatening infections

- No severe major organ toxicity

- Concurrent toxicity must be ≤ grade 2 except for the following, which may be
grade 3:

- Myelosuppression

- Hearing loss

- Alopecia

- Anorexia

- Nausea

- Hyperbilirubinemia from TPN

- Anxiety

- Hypomagnesemia

- No prior HAMA titer > 1,000 U/mL by ELISA


- No concurrent supplemental beta-glucan in food (e.g., bran cereals or mushrooms) or
as complementary medicine

- No other concurrent systemic anticancer medications (e.g., hormonal agents,
chemotherapy, investigational agents, or immunotherapy)

- Concurrent isotretinoin allowed after the second course of study treatment is
completed or if the patient develops human antimouse antibody (HAMA)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Shakeel Modak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

August 2014

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • disseminated neuroblastoma
  • Neuroblastoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021