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Trabectedin for Recurrent Grade II/III Meningioma

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ClinicalTrials.gov Identifier: NCT02234050
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:
The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

Condition or disease Intervention/treatment Phase
Recurrent High Grade Meningioma Drug: Trabectedin Other: Local standard of care Phase 2

Detailed Description:
This is a randomized open label multicenter comparative phase II trial. The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group
Study Start Date : July 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 16, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin

Arm Intervention/treatment
Experimental: Trabectedin
Patient will be treated with trabectedin
Drug: Trabectedin
Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
Other Name: Yondelis

Local standard of care
Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.
Other: Local standard of care
Left to the discretion of the investigator




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first ]

Secondary Outcome Measures :
  1. Progression Free Survival at 6 months (PFS-6), median PFS (mPFS) [ Time Frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first ]
  2. Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration. [ Time Frame: From the date of randomization until disease progression ]
  3. Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS) [ Time Frame: From the date of randomization up to the date of death, up to 12 months ]
  4. Safety (CTCAE v.4.0) [ Time Frame: From randomization up to 30 days after administration of the last dose of protocol treatment or until the start of a new antitumor therapy, whichever occurs first. ]
  5. Health-related Quality of life (HRQol) [ Time Frame: Untill six months after randomization ]


Information from the National Library of Medicine

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

Patient selection criteria

  • Age 18 or older
  • Histological diagnosis of WHO grade II (chordoid meningioma, clear cell meningioma, atypical meningioma) or WHO grade III (papillary meningioma, rhabdoid meningioma, anaplastic/malignant meningioma) according to WHO 2007 classification.
  • Radiologically documented progression of any existing tumor (growth > 25% in the last year) or appearance of new lesions (including intra- and extracranial manifestations)
  • No more option for local therapy (resection or radiotherapy) after maximal feasible surgery and radiotherapy
  • No prior systemic anti-neoplastic therapy for meningioma
  • Measurable disease (10 x10 mm) on cranial MRI no more than 2 weeks prior to randomization.
  • WHO performance status 0-2
  • Adequate liver, renal and hematological function within 4 weeks prior to randomization, defined as:

    • Neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL or hemoglobin ≥ 5.6 mmol/L, platelets ≥ 100 x 109/L
    • Total Bilirubin ≤ 1 x ULN, SGPT/ALT and SGOT/AST ≤ 2.5 x ULN
    • Alkaline phosphatase ≤ 2.5 x ULN; if alkaline phosphatase > 2.5 ULN, ALP hepatic isoenzyme and/or 5-nucleotidase and/or gamma glutyamyltransferase (GGT) must be within the normal range
    • Albumin ≥ 30 g/L
    • Serum creatinine ≤ 1.5 x ULN
    • Creatinine clearance > 30 ml/min as calculated by Cockcroft and Gault formula (see Appendix E)
    • Creatine phosphokinase (CPK) ≤ 2.5 x ULN
  • Normal cardiac function (LVEF assessed by MUGA or ECHO within normal range of the institution), normal 12 lead ECG (without clinically significant abnormalities). The following unstable cardiac conditions are not allowed:

    • Congestive heart failure
    • Angina pectoris
    • Myocardial infarction within 1 year before registration/randomization
    • Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mm Hg despite optimal medical therapy
    • Arrhythmias clinically significant
  • Life expectancy of at least 9 weeks
  • No history of any other invasive malignancy within the last 5 years (except adequately treated non-melanoma skin cancer, clinicaly localized and very low risk prostate cancer, and adequately treated cervical intraepithelial neoplasia)
  • No serious illness or medical conditions, specifically: active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis
  • No concomitant use of any other investigational agent or phenytoin
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. Women of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last study treatment. Men who are fertile must use effective contraception during treatment with trabectedin and for 5 months thereafter. A highly effective method of birth control is defined as one that results in low failure rate, i.e. less than 1% per year, when used consistently and correctly.
  • Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last study treatment.
  • No known MRI or CT, including contrast media, contraindications
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Patients with a buffer range from the normal values of +/- 5 % for hematology and +/- 10% for biochemistry are acceptable. A maximum of +/- 2 days for timelines may be acceptable
  • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

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): NCT02234050


  Show 47 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Matthias Preusser Medical University Vienna - General Hospital AKH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02234050     History of Changes
Other Study ID Numbers: EORTC-1320-BTG
2014-002446-47 ( EudraCT Number )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Grade 2 Chordoid meningioma
Grade 2 Clear cell meningioma
Grade 2 Atypical meningioma
Grade 3 Papillary meningioma
Grade 3 Rhabdoid meningioma
Grade 3 Anaplastic meningioma
Grade 3 Malignant meningioma
Additional relevant MeSH terms:
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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents