Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Moveme… (NCT00033293) | Clinical Trial Compass
CompletedPhase 3
Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
United States, Australia, Canada53 participantsStarted 2004-03-15
Plain-language summary
This randomized phase III 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. 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.
Who can participate
Age range
8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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)
* No prior IV gamma globulin therapy
* No prior chemotherapy
* Concurrent chemotherapy allowed
* No prior prednisone or corticotropin
* Patients who have received ≤ 14 days of steroids are eligible
* Concurrent surgery allowed
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Responders
Timeframe: Changes from baseline to 2 months, 6 months, and 1 year