Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme

NCT00984438 | Withdrawn Phase 1

• 1 other identifier: 08081101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery. The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• To assess disease free survival

  6 and 12 months

Study Arms (1)

BCNU wafter followed by chemotherapy

EXPERIMENTAL

Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year

Drug: BCNU Wafer; Drug: Irinotecan; Drug: Bevacizumab

Interventions

BCNU Wafer DRUG

Implantable during surgical resection into the tumor bed

Also known as: Gliadel Wafer

BCNU wafter followed by chemotherapy

Irinotecan DRUG

IV every 2 weeks for up to one year

Also known as: CPT-11

BCNU wafter followed by chemotherapy

Bevacizumab DRUG

IV every 2 weeks for up to one year

Also known as: Avastin

BCNU wafter followed by chemotherapy

Eligibility Criteria

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

You may qualify if:

• Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted.
• Must have had prior treatment with standard doses of Temodar
• KPS \>50; ECOG \<3
• Predicted life expectancy of \> 3 months
• Study entry must be within 5 weeks of surgical resection

You may not qualify if:

• Prior exposure to VEGF inhibitors or Irinotecan
• Intracranial bleed as defined by CT or MRI less than 6 months prior to entry
• GI bleed less than 6 months prior to entry
• Uncontrolled concurrent illness that would limit compliance with study requirements

Sponsors & Collaborators

• University of Cincinnati: lead
• Eisai Inc.: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Carmustine; Irinotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Margie Gerena-Lewis, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 25, 2019

Record last verified: 2013-06

Locations

US (1)