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Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Disseminated Neuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4S Neuroblastoma

Intervention: therapeutic immune globulin (Biological); clinical observation (Other); cyclophosphamide (Drug); prednisone (Drug); magnetic resonance imaging (Procedure); laboratory biomarker analysis (Other); Corticotropin-Releasing Hormone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Pedro De Alarcon, MD, Principal Investigator, Affiliation: Children's Oncology Group

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. Chemotherapy(cyclophosphamide), prednisone and intravenous gamma globulin all suppress the immune system which may be helpful in treating opsoclonus-myoclonus-ataxia (OMA).

Clinical Details

Official title: A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response of opsoclonus-myoclonus-ataxia (OMA) to treatment as rated by stance, gait, arm and hand function, opsoclonus, and mood/behavior

Secondary outcome:

Motor coordination as assessed by neurological examination and Vineland Adaptive Behavior Scale (VABS)

Functional outcome as assessed by age-appropriate neuropsychological testing

Biology of neuroblastoma associated opsoclonus-myoclonus-ataxia (OMA) syndrome specifically by MRI findings, anti-neuronal antibodies, cerebrospinal fluid (CSF) findings and tumor biology

Long-term prognosis for neurologic recovery by neurological examination

Tumor outcome in terms of event-free survival (EFS) rate defined as a relapse or progression of neuroblastoma, a second malignancy, or death

Tumor outcome in terms of overall survival rate

Detailed description: PRIMARY OBJECTIVES: I. Determine if immunosuppressive therapy with cyclophosphamide and prednisone is an effective therapy for neuroblastoma associated opsoclonus-myoclonus-ataxia (OMA) and can constitute a back-bone therapy upon which to build additional therapy. II. Determine in a randomized study if the addition of intravenous gammaglobulin therapy to the back-bone therapy of prednisone and cyclophosphamide improves response of neuroblastoma associated OMA. SECONDARY OBJECTIVES: I. Determine if intravenous gammaglobulin therapy improves the motor coordination of children diagnosed with neuroblastoma and presenting with OMA syndrome as assessed by neurological examination and the Vineland Adaptive Behavior Scale (VABS). II. Determine these regimens improve functional outcome in these patients. III. Investigate the biology of neuroblastoma associated OMA, with specific regard to magnetic resonance imaging (MRI) findings, anti-neuronal antibodies, cerebrospinal fluid (CSF) findings and tumor biology. IV. Define better the long-term prognosis for neurologic recovery in the child with neuroblastoma associated with OMA syndrome. V. Define the event-free and overall survival of patients with neuroblastoma associated opsoclonus-myoclonus-ataxia syndrome. OUTLINE: 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 for up to 10 years.

Eligibility

Minimum age: N/A. Maximum age: 8 Years. Gender(s): Both.

Criteria:

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

- 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

- Patients must be free of any organ dysfunction or disorder that the treating

physician feels may preclude the use of corticosteroid therapy (ACTH or prednisone), cyclophosphamide therapy or intravenous gammaglobulin therapy.

Locations and Contacts

Children's Hospital of Alabama, Birmingham, Alabama 35233, United States

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

University of Arizona Health Sciences Center, Tucson, Arizona 85724, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

British Columbia Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada

Loma Linda University Medical Center, Loma Linda, California 92354, United States

Miller Children's Hospital, Long Beach, California 90806, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Children's Hospital Central California, Madera, California 93636-8762, United States

Kaiser Permanente-Oakland, Oakland, California 94611, United States

Lucile Packard Children's Hospital Stanford University, Palo Alto, California 94304, United States

Rady Children's Hospital - San Diego, San Diego, California 92123, United States

University of California San Francisco Medical Center-Parnassus, San Francisco, California 94143, United States

Children's Hospital Colorado, Aurora, Colorado 80045, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado 80218, United States

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware 19803, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia 20057, United States

Broward Health Medical Center, Fort Lauderdale, Florida 33316, United States

Lee Memorial Health System, Fort Myers, Florida 33901, United States

Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207-8426, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida 33136, United States

Nemours Childrens Clinic - Orlando, Orlando, Florida 32806, United States

Nemours Children's Clinic - Pensacola, Pensacola, Florida 32504, United States

All Children's Hospital, Saint Petersburg, Florida 33701, United States

Saint Joseph Children's Hospital of Tampa, Tampa, Florida 33607, United States

Saint Mary's Hospital, West Palm Beach, Florida 33407, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia 30322, United States

Saint Luke's Mountain States Tumor Institute, Boise, Idaho 83712, United States

Childrens Memorial Hospital, Chicago, Illinois 60614, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637-1470, United States

Saint Jude Midwest Affiliate, Peoria, Illinois 61602, United States

Riley Hospital for Children, Indianapolis, Indiana 46202, United States

University of Kentucky, Lexington, Kentucky 40536, United States

Kosair Children's Hospital, Louisville, Kentucky 40202, United States

Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States

Sinai Hospital of Baltimore, Baltimore, Maryland 21215, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States

Saint John Hospital and Medical Center, Detroit, Michigan 48236, United States

Hurley Medical Center, Flint, Michigan 48502, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States

Michigan State University - Breslin Cancer Center, Lansing, Michigan 48910, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

The Childrens Mercy Hospital, Kansas City, Missouri 64108, United States

Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada 89106, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Morristown Memorial Hospital, Morristown, New Jersey 07962, United States

UMDNJ - Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

Saint Joseph's Regional Medical Center, Paterson, New Jersey 07503, United States

Overlook Hospital, Summit, New Jersey 07902, United States

The Children's Hospital at Westmead, Sydney, New South Wales 2145, Australia

Albany Medical Center, Albany, New York 12208, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

Columbia University Medical Center, New York, New York 10032, United States

State University of New York Upstate Medical University, Syracuse, New York 13210, United States

University of North Carolina, Chapel Hill, North Carolina 27599, United States

Carolinas Medical Center, Charlotte, North Carolina 28203, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

IWK Health Centre, Halifax, Nova Scotia B3J 3G9, Canada

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

The Children's Medical Center of Dayton, Dayton, Ohio 45404, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Legacy Emanuel Children's Hospital, Portland, Oregon 97227, United States

Legacy Emanuel Hospital and Health Center, Portland, Oregon 97227, United States

Penn State Hershey Children's Hospital, Hershey, Pennsylvania 17033, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States

Hospital Sainte-Justine, Montreal, Quebec H3T 1C5, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan S7N 4H4, Canada

Palmetto Health Richland, Columbia, South Carolina 29203, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina 29605, United States

Greenville Cancer Treatment Center, Greenville, South Carolina 29605, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota 57117-5134, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee 37916, United States

Texas Tech University Health Science Center-Amarillo, Amarillo, Texas 79106, United States

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States

Medical City Dallas Hospital, Dallas, Texas 75230, United States

Cook Children's Medical Center, Fort Worth, Texas 76104, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, United States

University of Vermont, Burlington, Vermont 05401, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington 99204, United States

West Virginia University Charleston, Charleston, West Virginia 25304, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6008, Australia

Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: March 2004
Last updated: March 3, 2015

Page last updated: August 23, 2015

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