Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Neuroblastoma

Treatments

Biological: monoclonal antibody 3F8

Biological: sargramostim

Study type

Interventional

Funder types

Other

Identifiers

NCT00002560

CDR0000063466 (Registry Identifier)

94-018

NCI-V94-0416

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.

Full description

OBJECTIVES:

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

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.

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

Enrollment

40 estimated patients

Sex

All

Ages

2 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy