View Clinical Trial (Medical Research Study)
A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
| City: |
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Jacksonville |
| State: |
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Florida |
| Zip Code: |
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32207 |
| Conditions: |
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Neuroblastoma |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, work in different ways to stop tumor cells from
dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining
chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal
muscle movement associated with neuroblastoma.
PURPOSE: This randomized phase II trial is studying cyclophosphamide, prednisone, and
immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone
in treating patients with abnormal trunk muscle movements associated with neuroblastoma.
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| Study Summary: |
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OBJECTIVES:
- Determine whether cyclophosphamide and prednisone with or without immune globulin is a
reasonable baseline standard therapy for pediatric patients with
neuroblastoma-associated opsoclonus-myoclonus-ataxia (OMA) syndrome.
- Determine whether immunosuppressive therapy with cyclophosphamide and prednisone is an
effective backbone therapy for OMA upon which to build additional treatment for these
patients.
- Determine whether these regimens improve OMA syndrome in these patients.
- Determine whether these regimens improve motor coordination in these patients.
- Determine whether these regimens improve functional outcome in these patients.
- Compare the event-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk
group per protocol COG-ANBL00B1 (low risk vs intermediate risk on COG-A3961 vs high risk on
COG-A3973).
- Chemotherapy: Patients with intermediate-risk or high-risk neuroblastoma receive
chemotherapy (including cyclophosphamide) according to the standard of care for the
stage of primary neuroblastoma, beginning on day 0.
Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive
cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in
the absence of disease progression or unacceptable toxicity.
All patients receive oral prednisone twice daily for 3 months and then every other day for
7-15 months.
- Immune globulin therapy: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive immune globulin IV on days -2 and -1, at weeks 4, 8, 12,
16, 20, and 24, and then at months 8, 10, and 12 after therapy. Treatment
continues in the absence of disease progression or unacceptable toxicity. Patients
with no response after 6 months go off treatment.
- Arm II: Patients do not receive immune globulin. Patients with unresponsive
opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months
may cross over to arm I.
Patients are followed during therapy every month for 6 months, at 1 year, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 18-52 patients (9-26 per treatment arm) will be accrued for
this study within 2-5.8 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Newly diagnosed neuroblastoma (NBL) or ganglioneuroblastoma with tumor-associated
opsoclonus-myoclonus-ataxia syndrome (OMA)
- Patients with NBL diagnosed within 6 months of OMA diagnosis AND patients with
OMA diagnosed within 6 months of NBL diagnosis are eligible
- Must enroll on study within 4 weeks of diagnosis
- Presence of opsoclonus, myoclonus, and/or ataxia associated with neuroblastoma
considered eligible
- Currently enrolled on COG neuroblastoma protocols: COG-ANBL00B1 or its successor
PATIENT CHARACTERISTICS:
Age:
- 8 and under at the time of diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on
age/gender as follows:
- ≤ 0.4 mg/dL (for patients 1 to 5 months of age)
- ≤ 0.5 mg/dL (for patients 6 to 11 months of age)
- ≤ 0.6 mg/dL (for patients 1 year of age)
- ≤ 0.8 mg/dL (for patients 2 to 5 years of age)
- ≤ 1.0 mg/dL (for patients 6 to 9 years of age)
- ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
- ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)
- ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)
- ≤ 1.6 mg/dL (for male patients ≥ 16 years of age)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior IV gamma globulin therapy
Chemotherapy:
- No prior chemotherapy
- Concurrent chemotherapy allowed
Endocrine therapy:
- No prior prednisone or corticotropin
- Patients who have received ≤ 14 days of steroids are eligible
Radiotherapy:
- Not specified
Surgery:
- Concurrent surgery allowed
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| NCT ID: |
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NCT00033293 |
| Primary Contact: |
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Study Chair
Pedro A. de Alarcon, MD
Saint Jude Midwest Affiliate
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| Backup Contact: |
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N/A |
| Location Contact: |
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Jacksonville, Florida 32207
United States
Eric S. Sandler
Phone: 904-697-3793
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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