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New treatment option for Glioblastoma Multiforme
Official title IA Carboplatin + Radiotherapy in Relapsing GBM
ClinicalTrials.gov ID: NCT03672721
What this study is testing
What is IA Carbo+ Radiation?
IA Carbo+ Radiation is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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%
You likely can't join if
- 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...
- Pregnancy (as objectivated by a positive b-HCG) or actively nursing
- Presence of an uncontrolled systemic infection
See the full eligibility criteria
- 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...
- 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). \-
- 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
- Pregnancy (as objectivated by a positive b-HCG) or actively nursing
- Presence of an uncontrolled systemic infection
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.