Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma

Brain Tumor Clinical Trial

Official title:

Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400816
• Other study ID #: CASE-CCF-4204
• Secondary ID: P30CA043703
• Status: Completed
• Phase: Phase 2
• Start date: August 2005
• Est. completion date: January 6, 2016

Study information

• Verified date: January 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 6, 2016
• Est. primary completion date: January 17, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• temozolomide
Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	Time in months to patient's disease progresses	Survival of Last Patient
Secondary	Toxicity--Count of Related Advers Events	Count of Treatment Related Toxicities	Post-Treatment