Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma

NCT00362570 | Completed Phase 2 DMC

• 1 other identifier: OSU-0222
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes radiation and chemotherapy. However, due to the potential long-term central nervous system toxicity from radiation, researchers speculate that it may be better to reserve radiation therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates that brain tumor patients with a deletion of the 1p chromosome have a higher response to the chemotherapy drug temozolomide.

Conditions

Oligoastrocytoma, Mixed; Anaplastic Oligodendroglioma

Keywords

Newly diagnosed

Outcome Measures

Primary Outcomes (1)

• Determine progression free survival and response rate in patients with newly diagnosed AO and MOA of Temozolomide given every other week.

  2007-20011

Secondary Outcomes (1)

• Assess the quality of life in this patient population using validated quality of life instruments.

  2007-2011

Interventions

Temozolomide DRUG

p.o.(by mouth), 150 mg/m2/d x days 1-7 and 15-21, given every 28 days \[i.e., 7 days on/7 days off\] using a standardized dosing range. Administration: Temozolomide will be administered on an empty stomach (i.e., 1 hour before or 2 hours after any oral intake).

Eligibility Criteria

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

You may qualify if:

• anaplastic oligodendroglioma or mixed oligoastrocytoma
• age \> 18
• Karnofsky status \> 70%
• adequate bone marrow, liver and renal function

You may not qualify if:

• prior chemotherapy or cranial irradiation

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Astrocytoma; 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

• Herbert Newton, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 10, 2006
• Study Start: May 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: March 1, 2011
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

US (1)