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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00033280
First received: April 9, 2002
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression) [ Time Frame: From start of treatment to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From registration to date of death or last follow-up ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2002
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Drug: temozolomide Procedure: neoadjuvant therapy Radiation: radiation therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033280

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Mayo Clinic
Jacksonville, Florida, United States, 32224
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, North Carolina
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States, 27533
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139-0000
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43206
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750-1635
Licking Memorial Hospital
Newark, Ohio, United States, 43055-2899
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
United States, South Carolina
Anderson Area Cancer Center
Anderson, South Carolina, United States, 29621-5705
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
  More Information

Additional Information:
Publications:
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.
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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00033280     History of Changes
Other Study ID Numbers: RTOG-BR-0131, CDR0000069270, RTOG-DEV-1080
Study First Received: April 9, 2002
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
adult anaplastic oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Oligodendroglioma
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014