Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme
Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme
5 other identifiers
interventional
52
1 country
1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving Gliadel wafer together with O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 10, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJuly 10, 2014
February 1, 2013
3.3 years
August 10, 2006
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-month overall survival
6 months
Secondary Outcomes (4)
One year overall survival
1 year
2 year overall survival
2 years
Median overall survival
2 years
Toxicity prevalence
2 years
Study Arms (1)
Gliadel wafers in combination with O6-benzylguanine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- DISEASE CHARACTERISTICS-
- Histologically confirmed recurrent glioblastoma multiforme (including gliosarcoma) which can be confirmed, if not earlier, by intraoperative pathological diagnosis on frozen section
- Evidence of a unilateral, single focus of measurable Central Nervous System (CNS) neoplasm on contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) scan that is supratentorial and measures ≥ 1.0 cm in diameter
- PATIENT CHARACTERISTICS-
- Greater than or equal to 18 years old
- Life expectancy of greater than 12 weeks
- Karnofsky performance status greater than or equal to 60%
- Absolute neutrophil count ≥ 1,000/millimeters (mm)³
- Platelet count ≥ 100,000/mm³
- Total Serum Bilirubin \< 2 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) \< 3 times ULN
- Blood urea nitrogen (BUN) \< 1.5 times ULN
- Creatinine \< 1.5 times ULN
- Negative pregnancy test
- Recovered from any effects of major surgery
- +4 more criteria
You may not qualify if:
- Patients who have not recovered from surgery
- Patients who are not neurologically stable for 2 weeks prior to study entry
- Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics
- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Known HIV positivity or AIDS-related illness
- Pregnant or nursing women
- Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
- Men who are not advised to use an effective method of contraception
- Patients taking immuno-suppressive agents other than prescribed corticosteroids
- Patients who have had prior treatment with Gliadel Wafers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Quinn JA, Jiang SX, Carter J, Reardon DA, Desjardins A, Vredenburgh JJ, Rich JN, Gururangan S, Friedman AH, Bigner DD, Sampson JH, McLendon RE, Herndon JE 2nd, Threatt S, Friedman HS. Phase II trial of Gliadel plus O6-benzylguanine in adults with recurrent glioblastoma multiforme. Clin Cancer Res. 2009 Feb 1;15(3):1064-8. doi: 10.1158/1078-0432.CCR-08-2130.
PMID: 19188181RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jennifer A. Quinn, MD
Duke Cancer Institute
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 10, 2006
First Posted
August 15, 2006
Study Start
April 1, 2004
Primary Completion
August 1, 2007
Study Completion
July 1, 2008
Last Updated
July 10, 2014
Record last verified: 2013-02