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PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA


Phase 2
2 Years
21 Years
Not Enrolling
Both
Neuroblastoma

Thank you

Trial Information

PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA


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.

Inclusion 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

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian H. Kushner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

94-018

NCT ID:

NCT00002560

Start Date:

February 1994

Completion Date:

April 2005

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021