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

April 9, 2002
November 7, 2013
July 2002
April 2005   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00033280 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: From registration to date of death or last follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: temozolomide
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Experimental: Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Interventions:
  • Drug: temozolomide
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
Not Provided
April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00033280
RTOG-BR-0131, CDR0000069270, RTOG-DEV-1080
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
Radiation Therapy Oncology Group
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP