Temozolomide in Treating Patients With Low-Grade Glioma

CNS Tumor, Adult Clinical Trial

Official title:

A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313729
• Other study ID #: CDR0000448883
• Secondary ID: 99102BTRC-9902H7
• Status: Completed
• Phase: Phase 2
• Start date: May 1999
• Est. completion date: June 12, 2017

Study information

• Verified date: January 2019
• Source: University of California, San Francisco
• 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 supratentorial low-grade glioma.

Description:

OBJECTIVES:

Primary

• Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

• Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.

• Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Other known NCT identifiers

• NCT00187642

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 12, 2017
• Est. primary completion date: September 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

• Oligodendroglioma

• Astrocytoma

• Oligoastrocytoma

• Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

• Study treatment must begin between 14 days and 4 months after surgical resection or biopsy

• Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 10 g/dL

• Creatinine < 1.5 times upper limit of normal (ULN)

• BUN < 1.5 times ULN

• Bilirubin < 1.5 times ULN

• SGOT < 2.5 times ULN

• Alkaline phosphatase < 2 times ULN

• Life expectancy > 12 weeks

• No nonmalignant systemic disease resulting in the patient being a poor medical risk

• No acute infection requiring intravenous antibiotics

• No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)

• No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

• Prior malignancies must be in remission for = 5 years

• No known HIV positivity

• No AIDS-related illness

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma

• No prior biological therapy or chemotherapy for low-grade glioma

• No other concurrent chemotherapy

• No concurrent radiotherapy or biological therapy

• No concurrent prophylactic growth factors

• No concurrent epoetin alfa

• No other concurrent investigational drugs

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Tumor, Adult
• Glioma

Intervention

Drug:
• temozolomide
Chemotherapy

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (Complete and Partial Response)	Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.	12 months
Secondary	Time to Tumor Progression	Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.	time from registration until date of the first documented progression, an average of 1 year
Secondary	Safety Profile	Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0	Time from registration up to 13 months