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Brain and Central Nervous System TumorsPhase 2NCT00099125

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

A Phase 2 study testing irinotecan hydrochloride, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Radiation Therapy Oncology Group at 118 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
irinotecan hydrochloride, temozolomide and adjuvant therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
118 sitesUnited States
Study dates
Nov 2004to Nov 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

118 sites in 1 country.

118 sites in 1 country

United States118 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron City Hospital

    Akron, Ohio, 44304

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87106

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Radiation Oncology Center

    Alliance, Ohio, 44601

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Cancer Institute of New Jersey at the Cooper University Hospital

    Camden, New Jersey, 08103

  • Cooper Cancer Institute

    Camden, New Jersey, 08103

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710

  • Cancer Institute of Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • John B. Amos Community Cancer Center

    Columbus, Georgia, 31904

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Dartmouth - Hitchcock Concord

    Concord, New Hampshire, 03301

  • Grandview Hospital

    Dayton, Ohio, 45405

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

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

    Eden, North Carolina, 27288

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Saint Agnes Medical Center

    Fresno, California, 93720

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610

  • Legacy Mount Hood Medical Center

    Glesham, Oregon, 97030

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27401

  • UPMC Cancer Center - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Providence Holy Cross Cancer Center

    Mission Hills, California, 91346-9600

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8032

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19718

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • UPMC - Shadyside

    Pittsburgh, Pennsylvania, 15232

  • UPMC - Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • Cancer Center at St. Clair Memorial Hospital

    Pittsburgh, Pennsylvania, 15243

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84603

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

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

    Rochester, New York, 14642

  • Regional Radiation Oncology Center at Rome

    Rome, Georgia, 30165

  • Community Cancer Center at Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • Radiological Associates of Sacramento Medical Group, Inc.

    Sacramento, California, 95815

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

    Salem, Ohio, 44460

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Community Medical Center

    Toms River, New Jersey, 08755

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19612

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • North Star Lodge Cancer Center

    Yakima, Washington, 98902

  • York Cancer Center at Wellspan Health

    York, Pennsylvania, 17405

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
irinotecan hydrochloride, temozolomide, adjuvant therapy, radiation therapy
Keywords
adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00099125
Study groupRoleWhat they receive
RT with chemotherapy + post-radiation chemotherapyExperimentalRadiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
Receives: Drug: irinotecan hydrochloride; Drug: temozolomide; Procedure: adjuvant therapy; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 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)

  1. Progression-free survival

    Measured: From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2004 (estimated)
  2. Study startNov 2004
  3. Primary completionOct 2006
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099125
Sponsor's protocol ID
RTOG-0420
Other IDs
CDR0000389229
Status last verified
Jan 2014
First submitted
8 Dec 2004
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan hydrochloride, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Radiation Therapy Oncology Group at 118 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00099125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.

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