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Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
beta-glucan
monoclonal antibody 3F8
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring disseminated neuroblastoma, recurrent neuroblastoma

Eligibility Criteria

undefined - 49 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 13, 2002
Last Updated
January 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00037011
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
disseminated neuroblastoma, recurrent neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
beta-glucan
Intervention Type
Biological
Intervention Name(s)
monoclonal antibody 3F8

10. Eligibility

Sex
All
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Kong V. Cheung, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma

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