Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
N/A
N/A
Both
Neuroblastoma
Trial Information
Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
OBJECTIVES:
- Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in
enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk
refractory neuroblastoma.
- Determine the antitumor activity of this regimen, in terms of assessing disease status
in the bone marrow by real-time quantitative reverse transcription polymerase chain
reaction, in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to refractory
disease (primary refractory [never had disease progression or disease recurrence] vs
secondary refractory [recurrent disease that did not respond completely to reinduction
therapy]).
- Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on
days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and
monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11.
- Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients
also receive oral isotretinoin twice daily on days -2 to 11.
Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2)
will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of neuroblastoma, as defined by 1 of the following:
- Histologically confirmed disease
- Bone marrow metastases plus high urine catecholamines
- High-risk disease meeting 1 of the following stage criteria:
- Stage IV, with 1 of the following:
- Any age with MYCN amplification
- > 18 months of age without MYCN amplification
- Stage III, with both of the following:
- Any age with MYCN amplification
- Unresectable disease
- Stage 4S with MYCN amplification
- Measurable or evaluable soft tissue disease
- Relapsed disease resistant to standard induction chemotherapy and salvage therapy
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- No severe hepatic toxicity ≥ grade 3
Renal
- No severe renal toxicity ≥ grade 3
Cardiovascular
- No severe cardiac toxicity ≥ grade 3
Pulmonary
- No severe pulmonary toxicity ≥ grade 3
Other
- Not pregnant
- Negative pregnancy test
- No severe neurologic toxicity ≥ grade 3
- No severe gastrointestinal toxicity ≥ grade 3
- No other severe major organ dysfunction except ototoxicity
- No history of allergy to mouse proteins
- No active life-threatening infection
- No human anti-mouse antibody titer > 1,000 ELISA units/mL
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease response as assessed by PT-PC at the end of 4 courses
Safety Issue:
No
Principal Investigator
Nai-Kong V. Cheung, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
04-050
NCT ID:
NCT00089258
Start Date:
July 2004
Completion Date:
Related Keywords:
- Neuroblastoma
- localized unresectable neuroblastoma
- disseminated neuroblastoma
- regional neuroblastoma
- stage 4S neuroblastoma
- recurrent neuroblastoma
- Neuroblastoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
