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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed
Phase 1

Conditions

Neuroblastoma

Treatments

Biological: beta-glucan
Biological: monoclonal antibody 3F8

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00037011
P30CA008748 (U.S. NIH Grant/Contract)
01-075
MSKCC-01075
NCI-G02-2067

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 49 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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