Combination Chemotherapy in Treating Children With Progressive Brain Tumors

NCT00002944 | Completed Phase 3 DMC

• 5 other identifiers: A9952CCG-A9952POG-A9952CCG-9952CDR0000065394
• Study Type: interventional
• Target: 428
• Locations: 6 countries
• Sites: 204

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.

Conditions

Brain Tumors; Central Nervous System Tumors

Keywords

recurrent childhood brain stem glioma; recurrent childhood visual pathway glioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; childhood low-grade cerebellar astrocytoma; childhood low-grade cerebral astrocytoma

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Compare the event-free survival as a result of treatment with either CV or TPCV

  Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years

Secondary Outcomes (1)

• Survival

  5 years

Study Arms (2)

Regimen A (CV Chemotherapy)

EXPERIMENTAL

Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC \>1,000/$L and platelet count \>100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.

Drug: carboplatin; Drug: vincristine sulfate

Regimen B (TPCV Chemotherapy)

EXPERIMENTAL

Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.

Drug: lomustine; Drug: procarbazine hydrochloride; Drug: thioguanine; Drug: vincristine sulfate

Interventions

carboplatin DRUG

Given IV

Also known as: Paraplatin, NSC-241240

Regimen A (CV Chemotherapy)

lomustine DRUG

Given IV

Also known as: CCNU, NSC-79037

Regimen B (TPCV Chemotherapy)

procarbazine hydrochloride DRUG

Given PO

Also known as: Matulane, NSC-77213

Regimen B (TPCV Chemotherapy)

thioguanine DRUG

Given PO

Also known as: 6-TG, NSC-752

Regimen B (TPCV Chemotherapy)

vincristine sulfate DRUG

Given PO and IV

Also known as: Oncovin, NSC-675574

Regimen A (CV Chemotherapy); Regimen B (TPCV Chemotherapy)

Eligibility Criteria

• Age: Up to 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Pathologically confirmed low grade residual astrocytomas or other eligible residual tumors of the brain interpreted as low grade (WHO grades I and II) such as the following: * Glial Tumors * Astrocytic tumors * Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic) * Pilocytic astrocytoma * Pleomorphic xanthoastrocytomas * Subependymal giant cell astrocytoma * Infantile desmoplastic astrocytoma * Low grade oligodendroglial tumors * Low grade oligodendroglioma * Low grade mixed gliomas * Oligo-astrocytoma * Neuronal Tumors * Ganglioglioma (excluding tumors with anaplastic astrocytic components) * Infantile desmoplastic ganglioglioma * Chiasmatic-hypothalamic tumor without histologic confirmation * All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study * Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression * Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation * Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically * No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm PATIENT CHARACTERISTICS: Age: * Under 10 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 (arm II) * Platelet count greater than 100,000/mm\^3 (arm II) Hepatic: * Not specified Renal: * Creatinine less than 1.5 times upper limit of normal for age OR * Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for the tumor Endocrine therapy: * Prior corticosteroid therapy allowed Radiotherapy: * No prior radiotherapy for the tumor Surgery: * See Disease characteristics Other: * Prior diuretic therapy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (204)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016-7710, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90027, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048-1865, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, 95798, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente Medical Center - Oakland

Sacramento, California, 95825, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123-4282, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Santa Barbara Cottage Children's Hospital

Santa Barbara, California, 93105, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051-5386, United States

Location

Children's Hospital Center for Cancer and Blood Disorders

Aurora, Colorado, 80045, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-2875, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, 33316, United States

Location

Lee Cancer Care of Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, 32806, United States

Location

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States

Location

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, 30322, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

Atlanta, Georgia, 30342, United States

Location

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-3730, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31208, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712-6297, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Advocate Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1174, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Swedish-American Regional Cancer Center

Rockford, Illinois, 61104-2315, United States

Location

Simmons Cooper Cancer Institute

Springfield, Illinois, 62794-9677, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40232, United States

Location

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, 71315-3198, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program at Barbara Bush Children's Hospital

Scarborough, Maine, 04074-9308, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, 01199-0001, United States

Location

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0286, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503-2560, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-5381, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805-1983, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Children's Hospitals and Clinics of Minnesota - St. Paul

Saint Paul, Minnesota, 55102-2392, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Air Force Base Medical Center

Keesler Air Force Base, Mississippi, 39534-2511, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Children's Hospital

Omaha, Nebraska, 68114-4113, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89109-2306, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

St. Barnabas Medical Center Cancer Center

Livingston, New Jersey, 07039, United States

Location

Overlook Hospital

Morristown, New Jersey, 07962, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Albany Medical Center Hospital

Albany, New York, 12208-3419, United States

Location

Maimonides Cancer Center at Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11040, United States

Location

Beth Israel Medical Center - Petrie Division

New York, New York, 10003-3803, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

St. Luke's - Roosevelt Hospital Center - St.Luke's Division

New York, New York, 10027, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-9446, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Dakota Cancer Institute at Dakota Clinic - South University

Fargo, North Dakota, 58103-4940, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-5000, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Dayton Children's - Dayton

Dayton, Ohio, 45404-1815, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

Tod Children's Hospital

Youngstown, Ohio, 44501, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland, Oregon, 97227, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, 29203, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37901, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Amarillo, Texas, 79106, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229-3993, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507-1971, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Carilion Medical Center for Children at Roanoke Community Hospital

Roanoke, Virginia, 24014, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99220-2555, United States

Location

Mary Bridge Children's Hospital and Health Center - Tacoma

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, 25302, United States

Location

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

John Hunter Hospital

Newcastle, New South Wales, 2310, Australia

Location

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 1Z2, Canada

Location

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, G1V 4G2, Canada

Location

University Medical Center Groningen

Groningen, 9713 EZ, Netherlands

Location

Starship Children's Health

Auckland, 1, New Zealand

Location

Swiss Pediatric Oncology Group Bern

Bern, 3010, Switzerland

Location

Swiss Pediatric Oncology Group Geneva

Geneva, 1205, Switzerland

Location

Related Publications (1)

• Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. doi: 10.1200/JCO.2011.36.6054. Epub 2012 Jun 4.

  PMID: 22665535 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Central Nervous System Neoplasms; Optic Nerve Glioma; Astrocytoma

Interventions

Carboplatin; Lomustine; Procarbazine; Thioguanine; Vincristine

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Joann Ater, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1997
• Primary Completion: February 1, 2006
• Study Completion: April 1, 2012
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

US (179); NZ (1); NL (1); AU (5); CA (16); CH (2)