Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 2 to 21 Other MSKCC-94018 NCI-V94-0416, NCT00002560

Objectives

1. Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.
2. Assess the biological effects of 3F8/GM-CSF in these patients.

Entry Criteria

Disease Characteristics:

• Neuroblastoma diagnosed by INSS criteria, i.e., either:
  • Histologic proof of disease

    OR

  • Tumor clumps in bone marrow plus elevated catecholamine levels



• Relapsed disease with poor long-term prognosis as indicated by at least one of the following:
  • N-myc amplification in tumor cells
  • Diploid chromosomal content in tumor cells
  • Distant skeletal metastases
  • Unresectable primary tumor crossing the midline
  • Bone marrow with greater than 10% tumor cells



• Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required



• No rapidly progressive disease



• Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• 2 to 21

Performance status:

• Not specified

Life expectancy:

• Greater than 8 weeks

Hematologic:

• Not specified

Hepatic:

• No grade 3/4 toxicity
• LDH no greater than 1.5 times upper limit of normal

Renal:

• Creatinine clearance at least 60 mL/min
• No grade 3/4 toxicity

Cardiovascular:

• No grade 3/4 toxicity

Pulmonary:

• No grade 3/4 toxicity

Other:

• No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
• No active life threatening infections
• No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
• No allergy to mouse proteins
• No pain requiring opiates

Expected Enrollment

A total of 11-40 patients will be accrued for this study over 4 years.

Outline

Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Brian Kushner, MD, Protocol chair		Ph: 212-639-6793; 800-525-2225 Email: kushnerb@mskcc.org

Registry Information
Official Title		PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
Trial Start Date		1994-02-08
Registered in ClinicalTrials.gov		NCT00002560
Date Submitted to PDQ		1994-02-08
Information Last Verified		2005-04-06
NCI Grant/Contract Number		P30-CA08748

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