Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis (TEMOBIC)
Primary Purpose
Oligodendroglioma; Oligoastrocytoma
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Oligodendroglioma; Oligoastrocytoma focused on measuring chemotherapy, BCNU-Temozolomide, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically proven oligodendroglioma or anaplastic oligoastrocytoma, newly diagnosed, resulting or not from a low grade glioma
- Tumor with measurable contrast enhancement (at least 15 mm in diameter)
- Surgical procedure limited to a biopsy or partial excision
- In the event of partial excision, an early postoperative check-up (<72 hours) performed at best by MRI, if not by CT, is required.
- Time between surgery and inclusion less than or equal to one and a half months (45 days)
- Age> 18 years old; <70
- Karnofsky index> 60
- Stable or reduced dose of corticosteroids in the 15 days prior to inclusion
- Polynuclear neutrophils> 1500; platelets> 100,000
- Bilirubin <1.25 x UNL; SGOT, SGPT, PAL <2.5 x UNL
- Absence of serious uncontrolled pathology
- Patient having received and understood the information and having signed the consent
Exclusion Criteria:
- Presence of GBM foci within the tumor
- Absence of evaluable residue after surgery
- Previous chemotherapy or radiotherapy
- Unsatisfactory expected monitoring conditions
- Pregnant or breastfeeding woman; lack of effective contraception if of childbearing age
- History of malignant disease (with the exception of CIS of the cervix and basal cell cancer)
- Contraindications related to the examination of the I.R.M.
Sites / Locations
- Assistance Publique - Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Administration of 6 cycles of chemotherapy
Outcomes
Primary Outcome Measures
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04755023
First Posted
February 10, 2021
Last Updated
February 11, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04755023
Brief Title
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
Acronym
TEMOBIC
Official Title
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2005 (Actual)
Primary Completion Date
March 15, 2009 (Actual)
Study Completion Date
December 15, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC.
If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC.
In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligodendroglioma; Oligoastrocytoma
Keywords
chemotherapy, BCNU-Temozolomide, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Administration of 6 cycles of chemotherapy
Intervention Type
Drug
Intervention Name(s)
Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide
Intervention Description
Chemotherapy (BCNU) will be delivered at Day 1. between day 1 and day 5, temolozomide will be administered . One cycle is planned every 6 weeks until 6 cycles.
Primary Outcome Measure Information:
Title
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Description
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Time Frame
At the end of Cycle 2 (each cycle is 28 days)
Title
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Description
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Time Frame
At the end of Cycle 4 (each cycle is 28 days)
Title
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Description
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Time Frame
At the end of Cycle 6 (each cycle is 28 days)
Title
Objective response rate of the BCNU-TMZ combination administered before radiotherapy
Description
In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment
Time Frame
1 month after radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven oligodendroglioma or anaplastic oligoastrocytoma, newly diagnosed, resulting or not from a low grade glioma
Tumor with measurable contrast enhancement (at least 15 mm in diameter)
Surgical procedure limited to a biopsy or partial excision
In the event of partial excision, an early postoperative check-up (<72 hours) performed at best by MRI, if not by CT, is required.
Time between surgery and inclusion less than or equal to one and a half months (45 days)
Age> 18 years old; <70
Karnofsky index> 60
Stable or reduced dose of corticosteroids in the 15 days prior to inclusion
Polynuclear neutrophils> 1500; platelets> 100,000
Bilirubin <1.25 x UNL; SGOT, SGPT, PAL <2.5 x UNL
Absence of serious uncontrolled pathology
Patient having received and understood the information and having signed the consent
Exclusion Criteria:
Presence of GBM foci within the tumor
Absence of evaluable residue after surgery
Previous chemotherapy or radiotherapy
Unsatisfactory expected monitoring conditions
Pregnant or breastfeeding woman; lack of effective contraception if of childbearing age
History of malignant disease (with the exception of CIS of the cervix and basal cell cancer)
Contraindications related to the examination of the I.R.M.
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis
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