Glioblastoma MultiformePhase 2CLARITY-1NCT00797940
Convection Enhanced Localized Administration of PRX321 With Real-time Imaging for Therapy of Recurrent Glioblastoma (CLARITY-1)
A Phase 2 study testing IL-4PE in people with Glioblastoma Multiforme, run by Sophiris Bio Corp.
Trial summary
A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the United States. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- IL-4PE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects at least 18 years old
- GBM at first recurrence or progression (i.e., disease progressed after any first-line therapy including surgery and radiotherapy as confirmed by MR imaging [MRI]); screening MRIs used to confirm eligibility must be available to the Investigator and the Independent Review Committee (IRC)
- Unilateral, unifocal, and supratentorial tumor, with a maximum diameter of 4 cm (i.e., maximum distance between the borders/edges of enhancing regions) visualized in any arbitrary imaging plane, as assessed by the IRC on MRI taken pre-study 2 weeks prior to catheter placement
- Histological confirmation of GBM (confirmation before primary therapy is acceptable)
- KPS ≥ 70
- If female of childbearing potential, an acceptable method of contraception must be combined with negative pregnancy test before entering the study and must be willing to use contraception for 2 months after treatment with PRX321; male subjects who are non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months) must be willing to use a barrier method of contraception for at least 2 months after treatment with PRX321. Acceptable methods of contraception are:
Show all 12Show fewer
- intra-uterine contraceptive device without hormone release system: placed at least 4 weeks prior to treatment with PRX321;
- simultaneous use of male condom and diaphragm + spermicide: starting at least 14 days prior to treatment with PRX321; or
- simultaneous use of male condom and female condom + spermicide: starting at least 14 days prior to treatment with PRX321
- Able to read, understand, and sign the informed consent document before undergoing any study-specific procedures or have a legal representative willing to do so
- Able and willing to undergo multiple MRI examinations
- Able and willing to comply with all study procedures
Who cannot join
- A tumor in the brain stem (not including fluid attenuation inversion recovery [FLAIR] changes), an infratentorial tumor, or multifocal satellite tumors
- Tumor with a clinically significant mass effect (> 5 mm midline shift) while on a stable corticosteroid dose
- Subjects with tumors that are completely liquefied (cystic or ring enhancement) in which convection would not be possible
- Tumor with geometric features that make them difficult to adequately cover the tumor volume with infusate by using CED catheters; these tumors include the following:
- Tumors that appear to wrap around ventricular structures, such that the catheter tips may be positioned within 1.0 cm of a ventricle or such that a large angle (such as an "elbow" or "L- shape") in the tumor shape is present and convection is likely to be compromised;
- Tumors in which post-surgical enhancement in T1 images in the margins around a resection cavity may be confused with recurring tumor; subjects in whom this enhancement exceeds 5 mm thickness are excluded
Show all 26Show fewer
- Clinical symptoms that are thought by the Investigator to be caused by uncontrolled increased intracranial pressure, hemorrhage, or edema of the brain
- Inadequate organ function, defined as 1 or more of the following:
- Hemoglobin < 9.0 g/dL (support with therapeutic erythropoietin products is acceptable);
- Absolute neutrophil count (ANC) < 1500/mm3 (unsupported by colony stimulating factors);
- Platelet count < 100,000/mm3 (unsupported by colony stimulating factors);
- Total bilirubin > 2.0 x upper limit of normal (ULN);
- Alanine transaminase (ALT) and aspartate transaminase (AST) > 3.0 x ULN;
- Prothrombin time (PT)/international normalized ratio (INR) > 1.5;
- Creatinine > 3.0 x ULN;
- glomerular filtration rate (GFR) < 30 mL/min/1.73 m2;
- Received previous treatment with anti-neoplastic chemotherapeutic agents or craniotomy within 4 weeks before catheter placement
- All subjects who had previously been treated with nitrosoureass must have a 6 to 8 week recovery period from prior toxicity before they can enroll into the study
- Have a known sensitivity or allergy to Gd-DTPA
- Received radiation therapy within 8 weeks prior to catheter placement
- Undergone prior radiosurgery boost (e.g., stereotactic radiosurgery) or other locally targeted therapy other than resection (e.g., Gliadel®, Cotara®) within 3 months of catheter placement
- Received investigational drug therapy for GBM within 4 weeks of catheter placement
- Presence of another type of malignancy within less than 5 years prior to the screening visit, except for adequately treated carcinoma in-situ of the cervix, prostate cancer not actively treated, and basal or squamous cell carcinoma of the skin
- Concurrent or a history of other major disease that could, in the opinion of the Investigator, put the subject at additional risk or interfere with the interpretation of the results of this trial
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits or other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject's enrollment incompatible with study objectives
- Life expectancy of less than 90 days
About this study
Official title: Phase II, Multi-center, Open-Label, Single-Arm Study of Intratumoral Infusion of PRX321 in Subjects With Glioblastoma Multiforme at First Recurrence or Progression
A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the United States. Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.
Primary Objective:
Read more
To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM).
Secondary Objectives:
To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or progressive GBM.
To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS), and progression-free survival (PFS).
Tertiary Objective:
To evaluate the relationship of observed infusate distribution with clinical and radiological responses.
- Conditions
- Glioblastoma Multiforme
- Being tested
- IL-4PE
- Keywords
- GBM, Glioblastoma, Glioblastoma Multiforme, Brain Tumor, Brain Cancer, Glioma
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-4PEDrug
Also called PRX321
Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Up to 42 subjects with first recurrence or progression of GBM Receives: Drug: IL-4PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM)
Measured: 6 months
Secondary outcomes (1)
To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS), and progression-free survival (PFS). To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or progressive GBM.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
Why it stopped: No funding for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophiris Bio Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797940
- Sponsor's protocol ID
- PRX321-1-05
- Acronym
- CLARITY-1
- Status last verified
- Nov 2012
- First submitted
- 24 Nov 2008
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multi-center, Open-Label, Single-Arm Study of Intratumoral Infusion of PRX321 in Subjects With Glioblastoma Multiforme at First Recurrence or Progression
- ClinicalTrials.gov ID
- NCT00797940
- Acronym / sponsor ID
- CLARITY-1 / PRX321-1-05
- Conditions
- Glioblastoma Multiforme
- Keywords
- GBM, Glioblastoma, Glioblastoma Multiforme, Brain Tumor, Brain Cancer, Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sophiris Bio CorpIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the United States. Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.
Primary Objective:
To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM).
Secondary Objectives:
To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or progressive GBM.
To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS), and progression-free survival (PFS).
Tertiary Objective:
To evaluate the relationship of observed infusate distribution with clinical and radiological responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: IL-4PEUp to 42 subjects with first recurrence or progression of GBM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects at least 18 years old
- GBM at first recurrence or progression (i.e., disease progressed after any first-line therapy including surgery and radiotherapy as confirmed by MR imaging [MRI]); screening MRIs used to confirm eligibility must be available to the Investigator and the Independent Review Committee (IRC)
- Unilateral, unifocal, and supratentorial tumor, with a maximum diameter of 4 cm (i.e., maximum distance between the borders/edges of enhancing regions) visualized in any arbitrary imaging plane, as assessed by the IRC on MRI taken pre-study 2 weeks prior to catheter placement
- Histological confirmation of GBM (confirmation before primary therapy is acceptable)
- KPS ≥ 70
Key exclusion criteria (26 listed)
- A tumor in the brain stem (not including fluid attenuation inversion recovery [FLAIR] changes), an infratentorial tumor, or multifocal satellite tumors
- Tumor with a clinically significant mass effect (> 5 mm midline shift) while on a stable corticosteroid dose
- Subjects with tumors that are completely liquefied (cystic or ring enhancement) in which convection would not be possible
- Tumor with geometric features that make them difficult to adequately cover the tumor volume with infusate by using CED catheters; these tumors include the following:
- Clinical symptoms that are thought by the Investigator to be caused by uncontrolled increased intracranial pressure, hemorrhage, or edema of the brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-4PEAlso: PRX321Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days. | Drug | Single Arm |
Primary outcome
To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM)
Time frame: 6 months
1 secondary outcome
To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS), and progression-free survival (PFS). To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or progressive GBM.
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
Related trials for Glioblastoma Multiforme
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IL-4PE in people with Glioblastoma Multiforme, run by Sophiris Bio Corp.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.