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Recurrent Adult Brain TumorPhase 2NCT00362921

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

A Phase 2 study testing Gliadel wafers in combination with O6-benzylguanine in people with Recurrent Adult Brain Tumor, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Adult Brain Tumor
What is being tested?
Gliadel wafers in combination with O6-benzylguanine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Apr 2004to Jul 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme

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.

Read the 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.

Being tested
Gliadel wafers in combination with O6-benzylguanine
Keywords
adult glioblastoma multiforme, adult gliosarcoma, recurrent adult brain tumor
Medical subject headings
Brain Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gliadel wafers in combination with O6-benzylguanineDrug

    Also called Gliadel wafer (carmustine)

Study groups in NCT00362921
Study groupRoleWhat they receive
Gliadel wafers in combination with O6-benzylguanineExperimentalNot described
Receives: Drug: Gliadel wafers in combination with O6-benzylguanine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month overall survival

    Measured: 6 months

Secondary outcomes (4)

  1. One year overall survival

    Measured: 1 year

  2. 2 year overall survival

    Measured: 2 years

  3. Median overall survival

    Measured: 2 years

  4. Toxicity prevalence

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startApr 2004
  3. Primary completionAug 2007
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00362921
Sponsor's protocol ID
Pro00004127
Other IDs
DUMC-5515-06-1R2, DUMC-5515-04-1R0, GP-DUMC-5515-06-1R2, CDR0000483768
Status last verified
Feb 2013
First submitted
10 Aug 2006
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19188181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gliadel wafers in combination with O6-benzylguanine in people with Recurrent Adult Brain Tumor, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month overall survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00362921, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.

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