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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00362921
First received: August 10, 2006
Last updated: July 9, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Adult Brain Tumor
Drug: Gliadel wafers in combination with O6-benzylguanine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 6-month overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One year overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 2 year overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicity prevalence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: April 2004
Study Completion Date: July 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gliadel wafers in combination with O6-benzylguanine Drug: Gliadel wafers in combination with O6-benzylguanine
Other Name: Gliadel wafer (carmustine)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362921

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Jennifer A. Quinn, MD Duke Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00362921     History of Changes
Other Study ID Numbers: Pro00004127, DUMC-5515-06-1R2, DUMC-5515-04-1R0, GP-DUMC-5515-06-1R2, CDR0000483768
Study First Received: August 10, 2006
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
adult glioblastoma multiforme
adult gliosarcoma
recurrent adult brain tumor

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carmustine
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014