Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuroblastoma
Intervention: beta-glucan (Drug); isotretinoin (Drug); monoclonal antibody 3F8 (Drug); sargramostim (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Nai-Kong V. Cheung, MD, PhD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
Summary
RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and
either kill them or deliver tumor-killing substances to them without harming normal cells.
Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal
antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining
different types of biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and
sargramostim together with monoclonal antibody 3F8 works in treating patients with
neuroblastoma that has not responded to previous treatment.
Clinical Details
Official title: Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-Risk Neuroblastoma
Study design: Treatment, Open Label
Primary outcome: Disease response as assessed by PT-PC at the end of 4 courses
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2004
Last updated: May 23, 2008
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