We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma (IDEB-glioma)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by BTG International Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481960
First Posted: June 25, 2015
Last Update Posted: October 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BTG International Inc.
  Purpose
A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).

Condition Intervention Phase
Glioma Procedure: CM-BC2 Irinotecan drug-eluting bead Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multi Centre Single Arm, Open Label Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as a Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable High Grade Glioma

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Safety measured by incidence of adverse events as assessed by CTCAE v4 [ Time Frame: 6 months ]
    safety as measured by adverse events including changes in physical exams, neurological function


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Progression-free survival at 6 months ]
    progression as assessed by MRI and date of death

  • Serum levels of irinotecan [ Time Frame: 6 months ]
    serum levels of drug (irinotecan)

  • Serum levels of SN-38, irinotecan metabolite [ Time Frame: 6 months ]
    serum levels of drug metabolite (SN-38)


Estimated Enrollment: 25
Study Start Date: July 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
Intraparenchymal administration of CM-BC2 irinotecan drug-eluting bead in recurrent high grade glioma.
Procedure: CM-BC2 Irinotecan drug-eluting bead
Other Name: IDEB

Detailed Description:

CM-BC2, irinotecan hydrochloride drug-eluting bead, is an investigational product being developed for direct injection in the tumor resection margin, in patients with recurrent high grade glioma (HGG), in order to prevent or delay tumor progression or recurrence.

Patients will be enrolled and receive CM-BC2 following surgical resection of the recurrent high grade glioma and will attend specified study visits until 6 months post surgery.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of Glioblastoma Multiforme (GBM) (World Health Organization grade III or IV)
  2. Patient will be considered a good candidate for resection and will have estimated life expectancy of at least 12 weeks as estimated by the Principal Investigator or designee. The decision to opt for resection of the recurrence must be independent of study selection.
  3. Tumour characteristics:

    • Single unilateral and supratentorial lesion
    • On clinician's assessment, must be operable under normal considerations of risk vs. benefit for condition and prognosis
  4. Patient will have received conventional treatment at the time of initial diagnosis, including surgery (biopsy or de-bulking), and/or radiotherapy, and/or chemotherapy
  5. Male or female; no racial exclusions; at least 18 years of age
  6. Pregnancy must be excluded in female patients by beta- HCG (Human Chorionic Gonadotropin); all patients agree to use adequate contraception for study duration, not become pregnant or father children during the study
  7. Karnofsky Performance Status of at least 50
  8. Patients must be able to understand consent and study instructions as well as follow prescribed instructions
  9. Patient must have signed written informed consent prior to study participation

Exclusion Criteria:

  1. Patient must not be enrolled in any other clinical trial for 30 days before or after participation in this trial
  2. History of allergic reactions attributed to compounds of similar chemical make-up or composition to CM-BC2, alginate or irinotecan; or has any other contraindications to irinotecan therapy
  3. Open communication between the ventricle CSF (cerebrospinal fluid) and tumour resection cavity/site must be avoided. In the case of opening ventricles during surgery, the surgeon must decide whether effective closure is possible by obstructing the gap with Gelfoam/other appropriate materials
  4. Tumor surgery, other than stereotactic biopsy of the high grade glioma, or other neurosurgery within 30 days prior to study entry
  5. Irinotecan chemotherapy within 30 days prior to study treatment
  6. Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry
  7. Loco-regional (intra-cranial) therapy for the treatment of high grade glioma, including administration of biodegradable polymer wafers containing Carmustine and/or brachytherapy, in the 6 months prior to study entry
  8. Significant liver function impairment: aminotransferase (AST) or alanine transaminase (ALT) greater than 2.5 x the upper limit of normal (ULN), or total bilirubin greater than 2 x ULN
  9. Significant renal impairment: creatinine greater than 2.0 mg/dL
  10. Coagulopathy Prothrombin time (PT) or partial thromboplastin time (APTT) of less than 1.5 x control, and/or platelet count of less than 100 x 10⁹/L
  11. Hb less than 8 g/dL and/or neutrophil count (ANC - Absolute Neutrophil Count) of less than 1 x 10⁹/L
  12. Any condition that, in the investigator's opinion, makes it in the patient's best interest not to participate in the study
  13. Pre-existing cerebral oedema that, in the surgeon's opinion, poses unacceptable risk of post-operative oedema. This decision may be at time of surgery.
  14. Presence of concurrent malignancy, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481960


Locations
France
Centre Hopsitalier Universitaire d'Angers
Angers, France, 49933
Germany
Prof. Erol Sandalcioglu
Hannover, Germany, 30167
Sponsors and Collaborators
BTG International Inc.
  More Information

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT02481960     History of Changes
Other Study ID Numbers: CA1018
First Submitted: June 23, 2015
First Posted: June 25, 2015
Last Update Posted: October 9, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action