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Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma



Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

For Condition: recurrent neuroblastoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/21 Years
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BrianKushner,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Brian  Kushner 212-639-6793


Additional Information:
Study ID Numbers:  CDR0000063466;  MSKCC-94018,NCI-V94-0416
Study Start Date: 
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002560

Other Recurrent Neuroblastoma Studies:
1. Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma

2. Docetaxel in Treating Children With Recurrent Solid Tumors

3. Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

4. beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma

5. Gene Therapy in Treating Children With Refractory or Recurrent Neuroblastoma

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