Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099125
• Other study ID #: RTOG-0420
• Secondary ID: CDR0000389229
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2004
• Last updated: January 23, 2014
• Start date: November 2004
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.

Description:

OBJECTIVES:

• Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.

• Determine the short- and long-term toxicity of this regimen in these patients.

• Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks.

• Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 2013
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision

• No gliomas graded less than glioblastoma multiforme

• No recurrent malignant gliomas

• No tumor foci below the tentorium or beyond the cranial vault

• Study therapy must begin = 5 weeks after surgery

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• At least 8 weeks

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 10 g/dL*

• Hematocrit = 30%* NOTE: *Transfusion allowed

Hepatic

• Bilirubin = 0.5 mg/dL

• ALT or AST = 2 times upper limit of normal

Renal

• Creatinine = 1.5 mg/dL

• BUN = 25 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-barrier contraception during and for 2 months after study participation

• No AIDS

• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder

• No other major medical illness or psychiatric impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent sargramostim (GM-CSF)

Chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry

Radiotherapy

• No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields

• Prior radiotherapy for stage T1 glottic cancer allowed

Surgery

• See Disease Characteristics

• Recovered from prior surgery

Other

• No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan

• Concurrent non-enzyme-inducing antiepileptic drugs allowed

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

• temozolomide

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron City Hospital	Akron	Ohio
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Radiation Oncology Center	Alliance	Ohio
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Randolph Hospital	Asheboro	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	St. Francis Hospital and Health Centers	Beech Grove	Indiana
United States	Green Mountain Oncology Group	Bennington	Vermont
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Cancer Institute of New Jersey at the Cooper University Hospital	Camden	New Jersey
United States	Cooper Cancer Institute	Camden	New Jersey
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Cancer Institute of Cape Girardeau	Cape Girardeau	Missouri
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	John B. Amos Community Cancer Center	Columbus	Georgia
United States	Dartmouth - Hitchcock Concord	Concord	New Hampshire
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital	Eden	North Carolina
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Saint Agnes Medical Center	Fresno	California
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Legacy Mount Hood Medical Center	Glesham	Oregon
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	UPMC Cancer Center - Arnold Palmer Pavilion	Greensburg	Pennsylvania
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	UPMC McKeesport	McKeesport	Pennsylvania
United States	Community Memorial Hospital	Menomonee Falls	Wisconsin
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Providence Holy Cross Cancer Center	Mission Hills	California
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Yale Comprehensive Cancer Center at Yale University School of Medicine	New Haven	Connecticut
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburg	Pennsylvania
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Cancer Center at St. Clair Memorial Hospital	Pittsburgh	Pennsylvania
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	UPMC - Passavant Hospital	Pittsburgh	Pennsylvania
United States	UPMC - Shadyside	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania
United States	Pomona Valley Hospital Medical Center	Pomona	California
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center	Portland	Oregon
United States	Institute of Oncology at Vilnius University	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York
United States	Regional Radiation Oncology Center at Rome	Rome	Georgia
United States	Community Cancer Center at Rutland Regional Medical Center	Rutland	Vermont
United States	Radiological Associates of Sacramento Medical Group, Inc.	Sacramento	California
United States	Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford	Salem	Ohio
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	Dixie Regional Medical Center	St. George	Utah
United States	Community Medical Center	Toms River	New Jersey
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Cancer Treatment Center	Wooster	Ohio
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	North Star Lodge Cancer Center	Yakima	Washington
United States	York Cancer Center at Wellspan Health	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lieberman FS, Tsien C, Berkey B, et al.: Phase II trial of concomitant low dose temozolomide with external beam radiation (EBRT) followed by 12 months of temozolomide and irinotecan for newly diagnosed glioblastoma (GBM): preliminary results of RTOG 04-20

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.	No
Secondary	Progression-free survival		From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.	No