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Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme

Primary Purpose

Recurrent Adult Brain Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gliadel wafers in combination with O6-benzylguanine
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Adult Brain Tumor focused on measuring adult glioblastoma multiforme, adult gliosarcoma, recurrent adult brain tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: 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 Patients or legal guardian must give written, informed consent. PRIOR CONCURRENT THERAPY- At least 2 weeks since prior surgical resection (if conducted) and recovered, unless there is unequivocal evidence of tumor progression At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas), unless there is unequivocal evidence of tumor progression.. However, patients treated with chemotherapeutic agents such as etoposide who would normally be retreated after shorter intervals (eg, 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy. EXCLUSION CRITERIA: 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.

Sites / Locations

  • Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gliadel wafers in combination with O6-benzylguanine

Arm Description

Outcomes

Primary Outcome Measures

6-month overall survival

Secondary Outcome Measures

One year overall survival
2 year overall survival
Median overall survival
Toxicity prevalence

Full Information

First Posted
August 10, 2006
Last Updated
July 9, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00362921
Brief Title
Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme
Official Title
Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Define the activity of Gliadel® wafers in combination with a 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme. Define the toxicity of Gliadel® wafers in combination with 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme. OUTLINE: This is an open-label study. Patients undergo surgical resection of tumor followed by placement of Gliadel® wafers . Within 6 hours after completion of surgery, patients receive a 1 hour high dose infusion of O6-benzylguanine followed by a lower dose continuous infusion for 5 days. Every 48 hours a repeat infusion of the high dose over 1 hour will be administered for a total of 3 doses. After completion of study treatment, patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 50 patients should be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Adult Brain Tumor
Keywords
adult glioblastoma multiforme, adult gliosarcoma, recurrent adult brain tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gliadel wafers in combination with O6-benzylguanine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gliadel wafers in combination with O6-benzylguanine
Other Intervention Name(s)
Gliadel wafer (carmustine)
Primary Outcome Measure Information:
Title
6-month overall survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
One year overall survival
Time Frame
1 year
Title
2 year overall survival
Time Frame
2 years
Title
Median overall survival
Time Frame
2 years
Title
Toxicity prevalence
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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 Patients or legal guardian must give written, informed consent. PRIOR CONCURRENT THERAPY- At least 2 weeks since prior surgical resection (if conducted) and recovered, unless there is unequivocal evidence of tumor progression At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas), unless there is unequivocal evidence of tumor progression.. However, patients treated with chemotherapeutic agents such as etoposide who would normally be retreated after shorter intervals (eg, 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy. EXCLUSION CRITERIA: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A. Quinn, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19188181
Citation
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.
Results Reference
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Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme

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