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

NCT00099125 | Completed Phase 2 DMC

• 2 other identifiers: RTOG-0420CDR0000389229
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 118

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastoma; adult gliosarcoma; adult glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Secondary Outcomes (1)

• 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.

Study Arms (1)

RT with chemotherapy + post-radiation chemotherapy

EXPERIMENTAL

Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy

Drug: irinotecan hydrochloride; Drug: temozolomide; Procedure: adjuvant therapy; Radiation: radiation therapy

Interventions

irinotecan hydrochloride DRUG

RT with chemotherapy + post-radiation chemotherapy

temozolomide DRUG

RT with chemotherapy + post-radiation chemotherapy

adjuvant therapy PROCEDURE

RT with chemotherapy + post-radiation chemotherapy

radiation therapy RADIATION

RT with chemotherapy + post-radiation chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (118)

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Saint Agnes Medical Center

Fresno, California, 93720, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Providence Holy Cross Cancer Center

Mission Hills, California, 91346-9600, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Radiological Associates of Sacramento Medical Group, Inc.

Sacramento, California, 95815, United States

Location

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, 06520-8032, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

John B. Amos Community Cancer Center

Columbus, Georgia, 31904, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Cancer Institute of Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Methodist Cancer Center at Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Dartmouth - Hitchcock Concord

Concord, New Hampshire, 03301, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Cooper Cancer Institute

Camden, New Jersey, 08103, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08818, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Lipson Cancer and Blood Center at Rochester General Hospital

Rochester, New York, 14621, United States

Location

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

Rochester, New York, 14642, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital

Eden, North Carolina, 27288, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27401, United States

Location

Annie Penn Cancer Center

Reidsville, North Carolina, 27320, United States

Location

Akron City Hospital

Akron, Ohio, 44304, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Radiation Oncology Center

Alliance, Ohio, 44601, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem, Ohio, 44460, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Legacy Mount Hood Medical Center

Glesham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Institute of Oncology at Vilnius University

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

UPMC Cancer Center - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Cancer Center at UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

UPMC - Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC - Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

Cancer Center at St. Clair Memorial Hospital

Pittsburgh, Pennsylvania, 15243, United States

Location

Reading Hospital and Medical Center

West Reading, Pennsylvania, 19612, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

York Cancer Center at Wellspan Health

York, Pennsylvania, 17405, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29304, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84603, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Community Cancer Center at Rutland Regional Medical Center

Rutland, Vermont, 05701, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

North Star Lodge Cancer Center

Yakima, Washington, 98902, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Community Memorial Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Related 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. [Abstract] J Clin Oncol 24 (Suppl 18): A-1510, 2006.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Irinotecan; Temozolomide; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Frank S. Lieberman, MD

  University of Pittsburgh

  STUDY CHAIR

• Christina I. Tsien, MD

  University of Michigan Rogel Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: November 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: November 1, 2013
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

US (118)