NCT00017147|CompletedPhase 3DMC

S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000068656S0001U10CA032102

Study Type

interventional

Target

183

Locations

1 country

Sites

163

Timeline

RegisteredJan 2003

StartedSep 2001

CompletionNov 2012

Brief 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. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

183

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2001

Longer than P75 for phase_3

Geographic Reach

1 country

163 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.2 years study duration

First Submitted

Initial submission to the registry

June 6, 2001

Completed

3 months until next milestone

Study Start

First participant enrolled

September 1, 2001

Completed

1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed

6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed

Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

4.7 years

First QC Date

June 6, 2001

Last Update Submit

January 28, 2013

Conditions

Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

Survival
assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5

Secondary Outcomes (3)

Progression-free survival
assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
Time to treatment failure
assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
Toxicity
assessed weekly for 42 weeks

Study Arms (2)

O6-BG + BCNU + Radiation Therapy

EXPERIMENTAL

O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.

Drug: carmustineRadiation: radiation therapyDrug: O6-Benzylguanine

BCNU + Radiation Therapy

ACTIVE COMPARATOR

BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.

Drug: carmustineRadiation: radiation therapy

Interventions

carmustineDRUG

40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG. 200 mg/m\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.

BCNU + Radiation TherapyO6-BG + BCNU + Radiation Therapy

radiation therapyRADIATION

5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.

BCNU + Radiation TherapyO6-BG + BCNU + Radiation Therapy

O6-BenzylguanineDRUG

120 mg/m\^2 IV over 1 hour on day 1 of each cycle

Also known as: O6-BG

O6-BG + BCNU + Radiation Therapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme or gliosarcoma * Biopsy or surgical resection within the past 28 days * MRI\* with gadolinium performed before registration * Patients who undergo a simple biopsy only require preoperative MRI\* with gadolinium * No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)\* * No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: \*If an MRI is not medically feasible, patients may have a CT scan with contrast PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN * PT/PTT no greater than 1.2 times ULN Renal: * Not specified Cardiac: * No severe cardiac disease, including any of the following: * Uncontrolled arrhythmias or conduction defects * Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis) * Recent coronary artery disease * Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg) Pulmonary: * DLCO at least 70% of predicted * No severe pulmonary disease Other: * HIV negative * No severe Cushing's syndrome * No known allergies to any of the study drugs * No major psychiatric illness * No poorly controlled diabetes complicated by steroid treatment * No other medical illness that cannot be adequately controlled or that would preclude study participation * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy * No other concurrent antitumor chemotherapy Endocrine therapy: * No concurrent hormonal therapy except postmenopausal estrogen replacement therapy * Corticosteroids at stable or decreasing dose for tumor edema allowed Radiotherapy: * See Disease Characteristics * No prior radiotherapy * No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s) Surgery: * See Disease Characteristics * No concurrent antitumor surgery Other: * No other concurrent investigational drugs * No other concurrent antineoplastic drugs or therapy

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

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (163)

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Banner Thunderbird Medical Center

Phoenix, Arizona, 85306, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

St. Anthony Central Hospital

Denver, Colorado, 80204, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80217-3364, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

St. Anthony North Hospital

Westminster, Colorado, 80030, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

West Florida Cancer Institute at West Florida Hospital - Pensacola

Pensacola, Florida, 32514, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, 83404, United States

Location

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

University of Illinois at Chicago Cancer Center

Chicago, Illinois, 60612, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Genesis Medical Center - West Campus

Davenport, Iowa, 52804, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, 67042, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Kansas, 64128, United States

Location

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

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, 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

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Baton Rouge General Regional Cancer Center

Baton Rouge, Louisiana, 70806, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Medical Center of Louisiana - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County General Hospital

Big Rapids, Michigan, 49307, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

St. Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

Freeman Cancer Institute at Freeman Health System

Joplin, Missouri, 64804, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, 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

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium