Clinical trial NCT00037011: Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
Official title: Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuroblastoma
Keywords: disseminated neuroblastoma
recurrent neuroblastoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nai-Kong V. Cheung, MD, PhD
role: STUDY_CHAIR
References: