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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003573
Other study ID # 9631
Secondary ID POG-9631CDR00000
Status Completed
Phase Phase 2
First received November 1, 1999
Last updated July 24, 2014
Start date November 1998
Est. completion date March 2008

Study information

Verified date July 2014
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.


Description:

OBJECTIVES:

- Assess the response rate and toxicity of oral etoposide and radiotherapy in children with newly diagnosed high stage medulloblastoma.

- Compare the response rate and toxicity of these patients to historical control patients registered on POG #9031.

- Estimate the 2-year event-free survival and overall survival of these patients.

- Evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin, cyclophosphamide, and vincristine following craniospinal irradiation in these patients.

OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).

Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date March 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 21 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically diagnosed advanced (high grade) childhood medulloblastoma

- Residual disease of at least 1.5 cm2 in size on MRI or CT scan OR

- Evidence of CNS or extraneural metastases

PATIENT CHARACTERISTICS:

Age:

- 3 to 21

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- SGPT less than 5 times normal

- Bilirubin less than 1.5 mg/dL

Renal:

- Creatinine less than 1.7 mg/dL OR

- Creatinine clearance greater than 70 mL/min

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- Not specified

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
filgrastim

Drug:
cisplatin

cyclophosphamide

etoposide

vincristine sulfate

Radiation:
radiation therapy


Locations

Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Children's Hospital Hamilton Ontario
Canada Hopital Sainte Justine Montreal Quebec
Canada McGill University Health Center - Montreal Children's Hospital Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Centre Hospitalier de L'Universite Laval Sainte Foy Quebec
Canada Hospital for Sick Children Toronto Ontario
Netherlands Academisch Ziekenhuis Groningen Groningen
Puerto Rico San Jorge Childrens Hospital Santurce
Switzerland Swiss Pediatric Oncology Group Bern Bern
Switzerland Clinique de Pediatrie Geneva
United States University of New Mexico School of Medicine Albuquerque New Mexico
United States Mission Saint Joseph's Health System Asheville North Carolina
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Johns Hopkins Oncology Center Baltimore Maryland
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Boston Floating Hospital Infants and Children Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Medical School-Charleston Charleston West Virginia
United States Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Healthcare Charlotte North Carolina
United States Children's Memorial Hospital, Chicago Chicago Illinois
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States University of Missouri-Columbia Hospital and Clinics Columbia Missouri
United States Medical City Dallas Hospital Dallas Texas
United States Simmons Cancer Center - Dallas Dallas Texas
United States Children's Hospital of Michigan Detroit Michigan
United States St. John's Hospital and Medical Center Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Inova Fairfax Hospital Falls Church Virginia
United States Hurley Medical Center Flint Michigan
United States Cook Children's Medical Center - Fort Worth Fort Worth Texas
United States Shands Hospital and Clinics, University of Florida Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States St. Vincent Hospital Green Bay Wisconsin
United States Children's Hospital of Greenville Hospital System Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Hackensack University Medical Center Hackensack New Jersey
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic Jacksonville Florida
United States James H. Quillen College of Medicine Johnson City Tennessee
United States University of Kansas Medical Center Kansas City Kansas
United States Keesler Medical Center - Keesler AFB Keesler AFB Mississippi
United States University of California San Diego Cancer Center La Jolla California
United States San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Miami Children's Hospital Miami Florida
United States Sylvester Cancer Center, University of Miami Miami Florida
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States MBCCOP - Gulf Coast Mobile Alabama
United States West Virginia University Hospitals Morgantown West Virginia
United States Yale Comprehensive Cancer Center New Haven Connecticut
United States Schneider Children's Hospital New Hyde Park New York
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Mount Sinai School of Medicine New York New York
United States Hope Children's Hospital Oak Lawn Illinois
United States Oklahoma Memorial Hospital Oklahoma City Oklahoma
United States Walt Disney Memorial Cancer Institute Orlando Florida
United States Lucile Packard Children's Hospital at Stanford Palo Alto California
United States Saint Jude Midwest Affiliate Peoria Illinois
United States St. Christopher's Hospital for Children Philadelphia Pennsylvania
United States CCOP - Columbia River Program Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Maine Children's Cancer Program Portland Maine
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Massey Cancer Center Richmond Virginia
United States Carilion Roanoke Community Hospital Roanoke Virginia
United States University of Rochester Cancer Center Rochester New York
United States Sutter Cancer Center Sacramento California
United States University of California Davis Medical Center Sacramento California
United States Cardinal Glennon Children's Hospital Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States MBCCOP - South Texas Pediatric San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Children's Hospital and Health Center San Diego California
United States Kaiser Permanente-Southern California Permanente Medical Group San Diego California
United States Naval Medical Center - San Diego San Diego California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States State University of New York Health Sciences Center - Stony Brook Stony Brook New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States CCOP - Florida Pediatric Tampa Florida
United States Scott and White Clinic Temple Texas
United States Arizona Cancer Center Tucson Arizona
United States Natalie Warren Bryant Cancer Center Tulsa Oklahoma
United States Walter Reed Army Medical Center Washington District of Columbia
United States St. Mary's Hospital West Palm Beach Florida
United States CCOP - Wichita Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Puerto Rico,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess the efficacy of oral etoposide at 50 mg/m2/day given concurrently with radiotherapy followed with dose intensive adjuvant chemotherapy in children with newly diagnosed high stage medulloblastoma It is possible that unacceptably high levels of toxicity may arise. For this reason, there is a 3-stage stopping rule designed to allow the Study Coordinator to stop this study early if it appears that the true proportion of eligible patients who suffer unacceptable levels of toxicity exceeds 10%. End of course 1 (week 10) Yes
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