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Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
monoclonal antibody 3F8
sargramostim
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 27, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002560
Brief Title
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
Official Title
PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 1994 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
recurrent neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
monoclonal antibody 3F8
Intervention Type
Biological
Intervention Name(s)
sargramostim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian H. Kushner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

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