Glioblastoma MultiformePhase 2NCT00104091
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
A Phase 2 study testing TP-38 in people with Glioblastoma Multiforme, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- TP-38
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jun 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients must fulfill all the following criteria:
- Previous histologically-confirmed diagnosis of primary GBM (glioblastoma multiforme, glioma grade 4 at time of first diagnosis).
- Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous resection (surgical or biopsy) and radiation therapy.
- Medically capable of undergoing the planned surgical gross total resection and the catheter placement.
- Age ≥ 18.
- Karnofsky Performance Status of ≥ 70%.
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- Life expectancy of ≥ 3 months.
- Patients must already be taking or begin taking corticosteroids at a stable dose of 4 mg every 6 hours for at least 72 hours prior to catheter placement.
- Patients must be capable of taking, or already taking, anticonvulsant medication.
- Patients must have read, signed, and dated an informed consent according to ICH-GCP, the local regulatory requirement and the rules followed at each institution.
Who cannot join
- Patients fulfilling any of the following criteria should not be enrolled in the study:
- Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
- Any form of brain radiation within 10 weeks of the start of the infusion.
- Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
- Prior intracavitary biologic response modifiers or monoclonal antibodies.
- Uncontrolled seizures.
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- Bilateral or multifocal tumors.
- Evidence of cerebral uncal herniation.
- Midline brain shift on MRI scan of > 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.
- Tumors involving the brainstem or cerebellum.
- Diffuse subependymal or CSF disease.
- Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrheic for at least 12 months to be considered non-childbearing.
- Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.
- Prior or concurrent investigational treatment within 30 days of study entry.
- Active infection requiring treatment or having an unexplained febrile illness.
- Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.
- Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).
About this study
Official title: A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.
- Conditions
- Glioblastoma Multiforme
- Being tested
- TP-38
- Keywords
- Gross Total Resection, Convection Enhanced Delivery, Recurrent Glioblastoma Multiforme
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-38Drug
TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 40 mL of TP-38 at a 100 nanograms/mL concentration Receives: Drug: TP-38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity
Measured: 26 weeks
Secondary outcomes (1)
Efficacy parameters including time to progression, safety, and survival
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionApr 2007
- Study completionJun 2007
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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104091
- Sponsor's protocol ID
- IXR-202-22-188
- Status last verified
- May 2011
- First submitted
- 22 Feb 2005
- Last updated
- 23 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection
- ClinicalTrials.gov ID
- NCT00104091
- Acronym / sponsor ID
- IXR-202-22-188
- Conditions
- Glioblastoma Multiforme
- Keywords
- Gross Total Resection, Convection Enhanced Delivery, Recurrent Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 23 Feb 2005 (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.
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TP-3840 mL of TP-38 at a 100 nanograms/mL concentration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Previous histologically-confirmed diagnosis of primary GBM (glioblastoma multiforme, glioma grade 4 at time of first diagnosis).
- Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous resection (surgical or biopsy) and radiation therapy.
- Medically capable of undergoing the planned surgical gross total resection and the catheter placement.
- Age ≥ 18.
- Karnofsky Performance Status of ≥ 70%.
Key exclusion criteria (17 listed)
- Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
- Any form of brain radiation within 10 weeks of the start of the infusion.
- Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
- Prior intracavitary biologic response modifiers or monoclonal antibodies.
- Uncontrolled seizures.
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 |
|---|---|---|
| TP-38TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38. | Drug | 1 |
Primary outcome
Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity
Time frame: 26 weeks
1 secondary outcome
Efficacy parameters including time to progression, safety, and survival
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2011.
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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 TP-38 in people with Glioblastoma Multiforme, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 23 May 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity (time frame: 26 weeks). 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 23 May 2011.