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

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: therapeutic immune globulin (Biological); clinical observation (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Pedro A. de Alarcon, MD, Study Chair, Affiliation: Saint Jude Midwest Affiliate

Summary

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.

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, Primary Purpose: Treatment

Primary outcome:

Efficacy as measured by assessment of response of opsoclonus, gait, neural, stance, arm and hand function at baseline, 6 months, and 1 year

Response as measured by assessment of opsoclonus, gait, neural, stance, arm and hand function at baseline, 6 months, and 1 year

Secondary outcome:

Motor coordination as assessed by neurological examination and Vineland Adaptive Behavior Scale at baseline, 1 and 5 years

Functional outcome as assessed by age-appropriate neuropsychological testing at baseline, 1 and 5 years

Biology of neuroblastoma associated opsoclonus-myoclonus-ataxia syndrome, specifically by MRI findings, anti-neuronal antibodies, SCF findings and tumor biology at baseline, 6 months, and 1 year

Long-term prognosis for neurologic recovery by neurological examination at baseline, 1 and 5 years

Tumor outcome in terms of event-free survival and overall survival at 1, 5, and 10 years

Detailed description: 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.

Eligibility

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

Criteria:

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

Locations and Contacts

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724-5024, United States; Recruiting
Clinical Trials Office - Arizona Cancer Center at University o, Phone: 520-626-9008

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Clinical Trial Office - Arkansas Cancer Research Center at Uni, Phone: 501-686-8274

Children's & Women's Hospital of British Columbia, Vancouver, British Columbia V6H 3V4, Canada; Recruiting
Caron Strahlendorf, Phone: 604-875-3576

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting
Clinical Trials Office - Loma Linda University Cancer Institut, Phone: 909-558-3375

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California 90801, United States; Recruiting
Jerry Z. Finklestein, Phone: 562-728-5000

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California 90048-1865, United States; Recruiting
Fataneh (Fae) Majlessipour, Phone: 310-423-4423

Children's Hospital Central California, Madera, California 93638-8762, United States; Recruiting
Vonda L. Crouse, Phone: 559-353-5480

Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California 95798, United States; Recruiting
Neyssa M. Marina, Phone: 650-723-5535

Kaiser Permanente Medical Center - Oakland, Sacramento, California 95825, United States; Recruiting
Vincent A. Kiley, Phone: 916-474-2326

Rady Children's Hospital - San Diego, San Diego, California 92123-4282, United States; Recruiting
Clinical Trials Office - Rady Children's Hospital - San Diego, Phone: 858-966-5934

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States; Recruiting
Clinical Trials Office - UCSF Helen Diller Family Comprehensi, Phone: 877-827-3222

Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States; Recruiting
Kelly W. Maloney, Phone: 720-777-6673

Presbyterian - St. Luke's Medical Center, Denver, Colorado 80218, United States; Recruiting
Clinical Trials Office - Presbyterian - St. Luke's Medical Cen, Phone: 303-839-6000

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States; Recruiting
Clinical Trials Office - Alfred I. duPont Hospital for Childre, Phone: 302-651-5755

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States; Recruiting
Clinical Trials Office - Children's National Medical Center, Phone: 202-884-2549

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States; Recruiting
Clinical Trials Office - Lombardi Comprehensive Cancer Center, Phone: 202-444-0381

Broward General Medical Center Cancer Center, Fort Lauderdale, Florida 33316, United States; Recruiting
Clinical Trials Office - Broward General Medical Center Cancer, Phone: 954-355-5346

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States; Recruiting
Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt, Phone: 877-680-0008

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting
Eric S. Sandler, Phone: 904-697-3793

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States; Recruiting
University of Miami Sylvester Comprehensive Cancer Center Clin, Phone: 866-574-5124, Email: Sylvester@emergingmed.com

Nemours Children's Clinic - Orlando, Orlando, Florida 32806, United States; Recruiting
Ramamoorthy Nagasubramanian, Phone: 407-650-7230

Nemours Children's Clinic - Pensacola, Pensacola, Florida 32504, United States; Recruiting
Jeffrey H. Schwartz, Phone: 850-505-4790

All Children's Hospital, Saint Petersburg, Florida 33701, United States; Recruiting
Gregory A. Hale, Phone: 727-767-4176

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida 33607, United States; Recruiting
Clinical Trials Office - St. Joseph's Cancer Institute, Phone: 800-882-4123

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States; Recruiting
Narayana Gowda, Phone: 561-844-6363

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia 30322, United States; Recruiting
Howard M. Katzenstein, Phone: 404-785-0853

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho 83712-6297, United States; Recruiting
Eugenia Chang, Phone: 208-381-2731

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States; Recruiting
Stewart Goldman, Phone: 773-880-3270

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States; Recruiting
Clinical Trials Office - University of Chicago Cancer Research, Phone: 773-834-7424

Saint Jude Midwest Affiliate, Peoria, Illinois 61637, United States; Recruiting
Stephen D. Smith, Phone: 309-624-4945

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States; Recruiting
Clinical Trials Office - Indiana University Cancer Center, Phone: 317-274-2552

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky 40536-0093, United States; Recruiting
Clinical Trials Office - Markey Cancer Center at University of, Phone: 859-257-3379

Kosair Children's Hospital, Louisville, Kentucky 40232, United States; Recruiting
Clinical Trials Office - Kosair Children's Hospital, Phone: 502-629-5500, Email: CancerResource@nortonhealthcare.org

Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana 71315-3198, United States; Recruiting
Clinical Trials Office - Tulane Cancer Center, Phone: 504-988-6121

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland 21215, United States; Recruiting
Joseph M. Wiley, Phone: 410-601-6266

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Suzanne Shusterman, Phone: 617-632-4901

Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Contact Person, Phone: 617-636-5535

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Clinical Trials Office - Massachusetts General Hospital, Phone: 877-726-5130

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States; Recruiting
Clinical Trials Office - Barbara Ann Karmanos Cancer Institute, Phone: 313-576-9363

Hurley Medical Center, Flint, Michigan 48503, United States; Recruiting
Clinical Trials Office - Hurley Medical Center, Phone: 810-762-8057

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States; Recruiting
Clinical Trials Office - Helen DeVos Children's Hospital, Phone: 616-391-3050

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States; Recruiting
Clincial Trials Office - Van Elslander Cancer Center at St. Jo, Phone: 313-343-3166

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan 48910, United States; Recruiting
Clinical Trials Office - Breslin Cancer Center at Ingham Regio, Phone: 517-334-2765

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States; Recruiting
Gail C. Megason, Phone: 601-984-5220

Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Maxine L. Hetherington, Phone: 816-234-3265

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89109-2306, United States; Recruiting
Jonathan Bernstein, Phone: 702-732-1493

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States; Recruiting
Clinical Trials Office - Hackensack University Medical Center, Phone: 201-996-2879

Overlook Hospital, Morristown, New Jersey 07962, United States; Recruiting
John J. Gregory, Phone: 973-971-6720

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States; Recruiting
Clinical Trials Office - Cancer Institute of New Jersey, Phone: 732-235-8675

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States; Recruiting
Clinical Trials Office - Newark Beth Israel Medical Center, Phone: 973-926-3136

St. Joseph's Hospital and Medical Center, Paterson, New Jersey 07503, United States; Recruiting
Mary A. Bonilla, Phone: 973-754-3349

Children's Hospital at Westmead, Westmead, New South Wales 2145, Australia; Recruiting
Geoffrey B. McCowage, Phone: 61298452122

Albany Medical Center Hospital, Albany, New York 12208-3419, United States; Recruiting
Vikramjit S. Kanwar, Phone: 518-262-5513x25265

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
Clinical Trials Office - Roswell Park Cancer Institute, Phone: 877-275-7724

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Clinical Trials Office - Herbert Irving Comprehensive Cancer C, Phone: 212-305-8615

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States; Recruiting
Clinical Trials Office - SUNY Upstate Medical University Hospi, Phone: 315-464-5476

New York Medical College, Valhalla, New York 10595, United States; Recruiting
Mehmet F. Ozkaynak, Phone: 914-493-7997

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States; Recruiting
Clinical Trials Office - Lineberger Comprehensive Cancer Cente, Phone: 877-668-0683; 919-966-4432

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States; Recruiting
Clinical Trials Office - Blumenthal Cancer Center at Carolinas, Phone: 704-355-2884

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States; Recruiting
Clinical Trials Office - Duke Comprehensive Cancer Center, Phone: 888-275-3853

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States; Recruiting
Clinical Trials Office - Wake Forest University Comprehensive, Phone: 336-713-6771

IWK Health Centre, Halifax, Nova Scotia B3J 3G9, Canada; Recruiting
Margaret C. Yhap, Phone: 902-470-8778

Akron Children's Hospital, Akron, Ohio 44308-1062, United States; Recruiting
Clinical Trials Office - Akron Children's Hospital, Phone: 330-543-3193

Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States; Recruiting
Laura T. Martin, Phone: 614-722-3582

Dayton Children's - Dayton, Dayton, Ohio 45404-1815, United States; Recruiting
Emmett H. Broxson, Phone: 937-641-3111

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States; Recruiting
Rene Y. McNall-Knapp, Phone: 405-271-5311

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States; Recruiting
Clinical Trials Office - Legacy Emanuel Hospital and Health Ce, Phone: 503-413-8199

Penn State Children's Hospital, Hershey, Pennsylvania 17033-0850, United States; Recruiting
John F. Kuttesch, Phone: 717-531-6012

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States; Recruiting
Elizabeth Fox, Phone: 267-425-3010

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134-1095, United States; Recruiting
Clinical Trials Office - St. Christopher's Hospital for Childr, Phone: 215-427-8991

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Clinical Trials Office - Children's Hospital of Pittsburgh, Phone: 412-692-7056

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada; Recruiting
Yvan Samson, Phone: 514-345-4969

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada; Recruiting
Christopher Mpofu, Phone: 306-655-2744

Palmetto Health South Carolina Cancer Center, Columbia, South Carolina 29203, United States; Recruiting
Clinical Trials Office - Palmetto Health South Carolina Cancer, Phone: 803-434-3680

Greenville Hospital Cancer Center, Greenville, South Carolina 29605, United States; Recruiting
Clinical Trials Office - Greenville Hospital Cancer Center, Phone: 864-241-6251

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States; Recruiting
Contact Person, Phone: 605-322-3000

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States; Recruiting
Clinical Trials Office - Sanford Cancer Center, Phone: 605-328-1367

East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States; Recruiting
Ray C. Pais, Phone: 865-541-8266

Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas 79106, United States; Recruiting
Osvaldo Regueira, Phone: 806-354-5434x282

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States; Recruiting
Clinical Trials Office - Driscoll Children's Hospital, Phone: 361-694-5311

Medical City Dallas Hospital, Dallas, Texas 75230, United States; Recruiting
Carl Lenarsky, Phone: 972-566-6647x4439

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States; Recruiting
Clinical Trials Office - Cook's Children's Medical Center, Phone: 682-885-2103

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States; Recruiting
Jaime Estrada, Phone: 210-575-7268

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States; Recruiting
Paul J. Thomas, Phone: 210-704-2187

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States; Recruiting
Julie R. Park, Phone: 206-987-2106

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington 99220-2555, United States; Recruiting
Judy L. Felgenhauer, Phone: 509-474-2777

West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia 25302, United States; Recruiting
Allen R. Chauvenet, Phone: 304-388-1552

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia; Recruiting
Catherine H. Cole, Phone: 011-6189340-8238

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States; Recruiting
Clinical Trials Office - St. Vincent Hospital Regional Cancer, Phone: 920-433-8889

Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin 54601, United States; Recruiting
Clinical Trials Office - Gundersen Lutheran Cancer Center, Phone: 608-775-2385, Email: cancerctr@gundluth.org

Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Michael E. Kelly, Phone: 414-456-4170

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2004
Last updated: April 5, 2011

Page last updated: February 07, 2013

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