Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

NCT00033280 | Completed Phase 2 DMC

• 2 other identifiers: RTOG-BR-0131CDR0000069270
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 39

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. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic oligodendroglioma; adult mixed glioma

Outcome Measures

Primary Outcomes (1)

• Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)

  From start of treatment to 6 months

Secondary Outcomes (1)

• Overall Survival

  From registration to date of death or last follow-up

Study Arms (1)

Pre-RT temozolomide, RT plus temozolomide

EXPERIMENTAL

Pre-radiation therapy (RT) temozolomide, RT plus temozolomide

Drug: temozolomide; Procedure: neoadjuvant therapy; Radiation: radiation therapy

Interventions

temozolomide DRUG

Pre-RT temozolomide, RT plus temozolomide

neoadjuvant therapy PROCEDURE

Pre-RT temozolomide, RT plus temozolomide

radiation therapy RADIATION

Pre-RT temozolomide, RT plus temozolomide

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma * Unifocal or multifocal disease * Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy * No equivocal oligodendroglial element * No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum) * No spinal cord tumors * No evidence of spinal drop metastasis or spread to noncontiguous meninges PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * Zubrod 0-1 Life expectancy: * More than 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 2 times normal * Aspartate aminotransferase (AST) no greater than 3 times normal * Alkaline phosphatase no greater than 2 times normal Renal: * Creatinine no greater than 1.5 times normal Other: * No active infection * No other medical problems that would preclude study participation * No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior chemotherapy for this malignancy * No prior temozolomide Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to the brain, head, or neck Surgery: * At least 14 days since prior surgery requiring general anesthesia

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
• NRG Oncology: collaborator

Study Sites (39)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Shands Cancer Center at the University of Florida Health Science Center

Gainesville, Florida, 32610-0385, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33256-2110, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Wayne Memorial Hospital, Inc.

Goldsboro, North Carolina, 27533, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139-0000, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Akron City Hospital

Akron, Ohio, 44304, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750-1635, United States

Location

Licking Memorial Hospital

Newark, Ohio, 43055-2899, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Anderson Area Cancer Center

Anderson, South Carolina, 29621-5705, 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, 84604, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, 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

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Related Publications (3)

• Vogelbaum MA, Berkey B, Peereboom D, Macdonald D, Giannini C, Suh JH, Jenkins R, Herman J, Brown P, Blumenthal DT, Biggs C, Schultz C, Mehta M. Phase II trial of preirradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: RTOG BR0131. Neuro Oncol. 2009 Apr;11(2):167-75. doi: 10.1215/15228517-2008-073. Epub 2008 Sep 8.

  PMID: 18779504 RESULT

• Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas: relationship between 1p/19q status and progression-free survival. [Abstract] J Clin Oncol 24 (Suppl 18): A-1517, 2006.

  RESULT

• Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas. [Abstract] J Clin Oncol 23 (Suppl 16): A-1520, 119s, 2005.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Oligodendroglioma; Glioma

Interventions

Temozolomide; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael A. Vogelbaum, MD, PhD

  The Cleveland Clinic

  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: April 9, 2002
• First Posted: January 27, 2003
• Study Start: July 1, 2002
• Primary Completion: April 1, 2005
• Study Completion: May 14, 2018
• Last Updated: October 22, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (38); CA (1)