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

NCT00400816 | Completed Phase 2 DMC

• 2 other identifiers: CASE-CCF-4204P30CA043703
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Nervous System Tumors; Brain Tumor

Keywords

adult anaplastic oligodendroglioma; adult mixed glioma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Time in months to patient's disease progresses

  Survival of Last Patient

Secondary Outcomes (1)

• Toxicity--Count of Related Advers Events

  Post-Treatment

Study Arms (1)

Temozolomide

EXPERIMENTAL

Temozolomide, 150 mg/m2/d x days 1-7 and 15-21

Drug: temozolomide

Interventions

temozolomide DRUG

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

Also known as: Temodar

Temozolomide

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Oligodendroglioma; Glioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

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

Study Officials

• David M. Peereboom, MD

  Case Comprehensive Cancer Center

  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: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: August 1, 2005
• Primary Completion: January 17, 2008
• Study Completion: January 6, 2016
• Last Updated: September 18, 2018

Record last verified: 2018-01

Locations

US (1)