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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033280
• Other study ID #: RTOG-BR-0131
• Secondary ID: CDR0000069270
• Status: Completed
• Phase: Phase 2
• Start date: July 2002
• Est. completion date: May 14, 2018

Study information

• Verified date: May 2018
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.

• Determine the toxicity of this regimen in these patients.

• Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).

Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.

Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.

Patients with CR after completion of neoadjuvant temozolomide undergo observation.

Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 14, 2018
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• temozolomide

Procedure:
• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Saint John Regional Hospital	Saint John	New Brunswick
United States	Akron City Hospital	Akron	Ohio
United States	Anderson Area Cancer Center	Anderson	South Carolina
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Shands Cancer Center at the University of Florida Health Science Center	Gainesville	Florida
United States	Wayne Memorial Hospital, Inc.	Goldsboro	North Carolina
United States	Mayo Clinic	Jacksonville	Florida
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Baptist Hospital of Miami	Miami	Florida
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Licking Memorial Hospital	Newark	Ohio
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Dixie Regional Medical Center	Saint George	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina

Sponsors (3)

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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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

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 statu

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 oligod — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)		From start of treatment to 6 months
Secondary	Overall Survival		From registration to date of death or last follow-up