A Study of Gliadel Followed by Avastin + Irinotecan for Glioblastoma Multiforme (GBM)

NCT00735436 | Terminated Phase 2 Results

• 1 other identifier: Pro00006308
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to use 24 week survival to assess the efficacy of the combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection. The secondary objectives are to determine the progression-free survival following the combination of Gliadel followed by Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and irinotecan.

Conditions

Malignant Glioma; Glioblastoma Multiforme; Gliosarcoma

Keywords

Malignant glioma; Glioblastoma multiforme; GBM; Gliosarcoma; Gliadel; Carmustine; Irinotecan; CPT-11; Camptosar; Avastin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• 24-week Overall Survival

  The percentage of participants surviving 24 weeks from the start of study treatment

  24 weeks

Secondary Outcomes (5)

• 24-week Progression-free Survival (PFS)

  24 weeks

• Median Progression-free Survival (PFS)

  Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 47 months

• Median Overall Survival (OS)

  Time in months from the start of study treatment to date of death due to any cause, assessed up to 47 months

• Incidence and Severity of Central Nervous System (CNS) Hemorrhage

  47 months

• Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities

  47 months

Study Arms (1)

Gliadel/Avastin/CPT-11

OTHER

Gliadel/Avastin/CPT-11

Drug: Gliadel/Avastin/CPT-11

Interventions

Gliadel/Avastin/CPT-11 DRUG

Also known as: bevacizumab, irinotecan

Gliadel/Avastin/CPT-11

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma). Patients have to be able to undergo a GTR.
• Age \> or = 18 years
• Evidence of a unilateral, single focus of measurable central nervous system (CNS) neoplasm on contrast-enhanced MRI, unless medically contraindicated (CT scan will then be used)
• Patients must have \< or = 2 disease progressions
• An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol
• Karnofsky \> or = 70%
• Hemoglobin \> or = 9.0 g/dl, absolute neutrophil count (ANC) \> or = 1,500 cells/microliters, platelets \> or = 125,000 cells/microliters
• Serum creatinine \< or = 1.5 mg/dl, serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin \< or = 1.5 times upper limit of normal
• Patients on corticosteroids must have been on a stable dose for 1 week prior to entry, if clinically possible, and the dose should not be escalated over entry dose level
• If patient received chemotherapy or investigational agent as part of their prior therapy, the patient must recover from all toxicities (\> or = Grade 1) prior to enrollment on this protocol
• Signed informed consent approved by the Institutional Review Board
• No evidence of CNS hemorrhage on the baseline MRI or CT scans
• If sexually active, patients will take contraceptive measures for the duration of treatment as stated in the informed consent

You may not qualify if:

• Pregnancy or breast feeding. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to treatment administration
• Multifocal disease
• Prior treatment with Gliadel
• Prior treatment with CPT-11 or Avastin
• Prior stereotactic radiosurgery or brachytherapy
• Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
• Active infection requiring IV antibiotics
• Acute or chronic renal insufficiency (a glomerular filtration rate (GFR) \<30 mL/min/1.73m2) or acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period
• Inability, in the opinion of the study investigator, to comply with study and/or follow-up procedures
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
• Life expectancy of less than 12 weeks
• Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure

Sponsors & Collaborators

• Duke University: lead
• Eisai Inc.: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Duke University Medical Center Clinical Trials
• The Preston Robert Tisch Brain Tumor Center

MeSH Terms

Conditions

Glioma; Glioblastoma; Gliosarcoma

Interventions

carmustine, poliferprosan 20 drug combination; Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Annick Desjardins, MD, FRCPC
• Organization: Duke University Medical Center

annick.desjardins@dm.duke.edu

Study Officials

• Annick Desjardins, MD, FRCPC

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2012
• Last Updated: February 11, 2013
• Results First Posted: February 4, 2013

Record last verified: 2012-12

Locations

US (1)