Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis (TEMOBIC)

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.

Study Overview

• Status: Completed
• Conditions: Oligodendroglioma; Oligoastrocytoma
• Intervention / Treatment: Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Assistance Publique - Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Administration of 6 cycles of chemotherapy	Drug: Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate of the BCNU-TMZ combination administered before radiotherapy	In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment	At the end of Cycle 2 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy	In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment	At the end of Cycle 4 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy	In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment	At the end of Cycle 6 (each cycle is 28 days)
Objective response rate of the BCNU-TMZ combination administered before radiotherapy	In oligodendrogliomas and anaplasic oligoastrocytomas as the first line of treatment	1 month after radiotherapy

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2005
• Primary Completion (Actual): March 15, 2009
• Study Completion (Actual): December 15, 2010

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: chemotherapy; radiotherapy; BCNU-Temozolomide
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Oligodendroglioma
• Other Study ID Numbers: 2004-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No