Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial

Anaplastic Oligodendroglioma Clinical Trial

Official title:

The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847235
• Other study ID #: OD_OA
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2013
• Last updated: April 22, 2016
• Start date: May 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.

Description:

Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion.

During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven anaplastic oligodendroglioma or oligoastrocytoma

• Progressed or relapsed after surgery or radiation therapy

• Female or male aged 20 years or over

• At least 1 measurable mass lesion

• ECOG performance status 0-3

• Adequate organ function

• absolute neutrophil count > 1,500/µL

• platelet count > 75,000/µL

• hemoglobin greater than 9 g/dL or 900g/L

• serum creatinine less than 1.5 times the upper limit of laboratory normal

• total serum bilirubin less than 1.5 times the upper limit of laboratory normal

• AST or ALT less than three times the upper limit of laboratory normal

Exclusion Criteria:

• Prior course of temozolomide

• Combined glioblastoma

• Pregnant woman

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Oligoastrocytoma
• Anaplastic Oligodendroglioma
• Oligodendroglioma

Intervention

Drug:
• Temozolomide
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Cairncross JG, Ueki K, Zlatescu MC, Lisle DK, Finkelstein DM, Hammond RR, Silver JS, Stark PC, Macdonald DR, Ino Y, Ramsay DA, Louis DN. Specific genetic predictors of chemotherapeutic response and survival in patients with anaplastic oligodendrogliomas. J Natl Cancer Inst. 1998 Oct 7;90(19):1473-9. — View Citation

Gan HK, Rosenthal MA, Dowling A, Kalnins R, Algar E, Wong N, Benson A, Woods AM, Cher L. A phase II trial of primary temozolomide in patients with grade III oligodendroglial brain tumors. Neuro Oncol. 2010 May;12(5):500-7. doi: 10.1093/neuonc/nop065. Epub 2010 Feb 8. — View Citation

Möllemann M, Wolter M, Felsberg J, Collins VP, Reifenberger G. Frequent promoter hypermethylation and low expression of the MGMT gene in oligodendroglial tumors. Int J Cancer. 2005 Jan 20;113(3):379-85. — View Citation

Perry JR, Bélanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B, Forsyth P, Pouliot JF. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010 Apr 20;28(12):2051-7. doi: 10.1200/JCO.2009.26.5520. Epub 2010 Mar 22. Erratum in: J Clin Oncol. 2010 Jul 20;28(21):3543. — View Citation

Perry JR, Rizek P, Cashman R, Morrison M, Morrison T. Temozolomide rechallenge in recurrent malignant glioma by using a continuous temozolomide schedule: the "rescue" approach. Cancer. 2008 Oct 15;113(8):2152-7. doi: 10.1002/cncr.23813. — View Citation

Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. — View Citation

Van den Bent MJ, Reni M, Gatta G, Vecht C. Oligodendroglioma. Crit Rev Oncol Hematol. 2008 Jun;66(3):262-72. doi: 10.1016/j.critrevonc.2007.11.007. Epub 2008 Feb 12. Review. — View Citation

Yung WK, Prados MD, Yaya-Tur R, Rosenfeld SS, Brada M, Friedman HS, Albright R, Olson J, Chang SM, O'Neill AM, Friedman AH, Bruner J, Yue N, Dugan M, Zaknoen S, Levin VA. Multicenter phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor Group. J Clin Oncol. 1999 Sep;17(9):2762-71. Erratum in: J Clin Oncol 1999 Nov;17(11):3693. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive biomarker study		1 year	No
Primary	Progression free survival (PFS)	PFS will be examined with Kaplan-Meier method.	6 month	No
Secondary	Objective response rate (ORR)	ORR will be evaluated through the frequency analysis with 95% confidence interval.	1 year	No
Secondary	Overall survival (OS)	OS will be examined with Kaplan-Meier method.	1 years	No
Secondary	progression-free survival (PFS)	PFS will be examined with Kaplan-Meier method.	1 year	No
Secondary	Number of Participants with Adverse Events	Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics.	1 years	Yes