Clinical trial NCT00400816: Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Official title: Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Nervous System Tumors
Brain Tumor
Keywords: adult anaplastic oligodendroglioma
adult mixed glioma
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.

Detailed description: OBJECTIVES:

* Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
* Determine the response rate in these patients.
* Assess the quality of life of patients with AO or MOA treated with this regimen.

OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).

Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:

  * Bidimensionally measurable disease
  * Evaluable disease
  * Nonevaluable disease as demonstrated by gross total surgical resection
* No immediate need for cranial irradiation

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Life expectancy ≥ 12 weeks
* Absolute granulocyte count ≥ 1,500/mm³
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.0 times ULN
* AST ≤ 3.0 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No infection requiring systemic antibiotics within the past 14 days
* No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
* No unrelated medical problems that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for this malignancy
* No prior radiotherapy to the brain
* No surgery requiring general anesthesia \> 2 hours in duration within the past 10 days
* No prior temozolomide
* Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry

Primary outcomes:
measure: Progression-Free Survival
timeFrame: Survival of Last Patient
Secondary outcomes:
measure: Toxicity--Count of Related Advers Events
timeFrame: Post-Treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: David M. Peereboom, MD
role: STUDY_CHAIR
References: