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

NCT01847235 | Completed Phase 2 DMC

• 1 other identifier: OD_OA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma

Keywords

Temozolomide

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS will be examined with Kaplan-Meier method.

  6 month

Secondary Outcomes (4)

• Objective response rate (ORR)

  1 year

• Overall survival (OS)

  1 years

• progression-free survival (PFS)

  1 year

• Number of Participants with Adverse Events

  1 years

Other Outcomes (1)

• Predictive biomarker study

  1 year

Study Arms (1)

Temozolomide

EXPERIMENTAL

Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days

Drug: Temozolomide

Interventions

Temozolomide DRUG

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

Also known as: Temodal

Temozolomide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior course of temozolomide
• Combined glioblastoma
• Pregnant woman

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (8)

• 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. doi: 10.1056/NEJMoa043330.

  PMID: 15758009 BACKGROUND

• 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.

  PMID: 18756530 BACKGROUND

• Perry JR, Belanger 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.

  PMID: 20308655 BACKGROUND

• 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. doi: 10.1200/JCO.1999.17.9.2762.

  PMID: 10561351 BACKGROUND

• 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. doi: 10.1093/jnci/90.19.1473.

  PMID: 9776413 BACKGROUND

• 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.

  PMID: 18272388 BACKGROUND

• Mollemann 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. doi: 10.1002/ijc.20575.

  PMID: 15455350 BACKGROUND

• 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.

  PMID: 20406900 BACKGROUND

MeSH Terms

Conditions

Oligodendroglioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tae Min Kim, MD, PhD

  Seoul National University Hospital, Seoul, South Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 6, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

KR (1)