Fact CheckerSign in

NCT03672721RecruitingPhase 1/2

IA Carboplatin + Radiotherapy in Relapsing GBM

A Phase II Study in Relapsing Glioblastoma of Intraarterial Concurrent Chemoradiation Therapy Using IA Carboplatin

Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Treatment of glioblastoma involves an optimal surgery, followed by a combination of radiation and temozolomide chemotherapy. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is the norm. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which limits drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, the investigators have observed responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival 23 months. How can this be improved? By coupling radiation with a chemotherapeutic which is also a potent radiosensitizer such as carboplatin. Study design: In this phase I/II trial, patients will be treated at recurrence; a surgery will be performed for cytoreduction and to obtain tumor sample, followed with a combination of re-irradiation and IA carboplatin chemotherapy. A careful escalation scheme from 1.5Gy/fraction up to 3.5Gy/fraction will allow the investigators to determine the optimal re-irradiation dose (10 fractions of radiation over 2 weeks). Toxicity will be assessed according to the NCIC common toxicity criteria. Combined with radiation, patients will receive 2 treatments of IA carboplatin, 400 mg/m2, 4 hours prior to the first and the sixth radiation fraction. IA treatments will then be continued on a monthly basis, up to a total of 12 months, or until progression. Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. The investigators will also acquire a sequence that enables the measurement of cerebral blood flow, cerebral blood volume and blood vessel permeability that are all relevant to understand the delivery of therapeutics to the CNS. Primary outcome will be OS and PFS. Secondary outcome will be QOL, neurocognition, and carboplatin delivery. In vitro intracellular carboplatin accumulation: Tumor samples from re-operation will be be analyzed for intracellular Pt concentration by ICP-MS. The amount of Pt bound to DNA will be measured. The level of apoptosis will be determined for each of the sample. Putting together these data will allow to correlate clinical and radiological response to QOL, NC (MOCA), and to delivery surrogates for the IA infusion and intracellular penetration of carboplatin.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
35 (estimated)
First submitted
11 Jul 2018
Start date
10 Jul 2018
Primary completion date
10 Dec 2025
Lead sponsor
Université de Sherbrooke
Diseases
Glioblastoma
NCT number
NCT03672721

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 35
  • From 10 Jul 2018 to the primary completion date, 10 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of a severe psychiatric or medical condition that would interfere with treatment administration or study enrolment.
  • Presence of an active auto-immune disease.
  • Occurrence of another malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Presence of an uncontrolled systemic infection

Other

  • Pregnancy (as objectivated by a positive b-HCG) or actively nursing

Who the study is looking for

  • Histological diagnosis of glioblastoma multiforme
  • Radiological progression on an MRI scan, according to the RANO criteria, in the context of a known glioblastoma multiforme, already treated with the Stupp protocol of combined radiotherapy-Temozolomide, and progressing. This implies a measurable disease on MRI.
  • Prior radiotherapy and temozolomide, as per the Stupp protocol, no sooner than 4 weeks, is permitted.
  • 18 of age and over
  • Performance status: Karnofsky 60-100%
  • Haematopoietic parameters at enrolment:
    • Platelet counts \> 100,000/mm\^3
    • Hemoglobin \> 8 g/dL
    • Absolute neutrophil count \> 1,500/mm\^3
    • No impaired bone marrow function
  • Hepatic parameters at enrolment:
    • Bilirubin ≤ 2 times normal value
    • AST and ALT ≤ 2 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN (unless attributed to tumor)
    • No impaired hepatic function
  • Renal parameters at enrollment:
    • No impaired renal function
    • Creatinine no greater than 1.5 fold of the normal value
    • Creatinine clearance \> 30 ml/min.
  • Normal ECG
  • Written informed consent obtained
  • Patient should be either sterile or else use a contraceptive strategy (for at least 2 months prior to study accrual).
    • \-

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHUS
Coordinator of this site? Confirm its status		SherbrookeCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.