Glioblastoma MultiformePhase 2NCT00062504
Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas
A Phase 2 study testing Talampanel in people with Glioblastoma Multiforme and Anaplastic Astrocytoma, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma
- What is being tested?
- Talampanel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Apr 2006
- 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
- Patients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
- Patients must have unequivocal evidence for tumor progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
- They have recovered from the effects of surgery.
- Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:
- no later than 96 hours in the immediate post-operative period or
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- at least 4 weeks post-operatively, and
- within 14 days of registration, and
- on a steroid dosage that has been stable for at least 5 days.
- If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated.
- Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be > 18 years old, and with a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60.
- Patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy, two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count).
- Patients must have adequate bone marrow function (ANC > 1,200/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT and bilirubin < 2 times ULN), and adequate renal function (serum creatinine < 1.5 mg/dL otherwise a measured 24-hour creatinine clearance > 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects.
- Patients must not have active infection requiring IV antibiotics.
- Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with Talampanel. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
Who cannot join
- Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible that would significantly increase the risk of using talampanel.
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Patients known to have an active, life-threatening malignancy.
About this study
Official title: A Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.
To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.
Read the detailed description
To determine the efficacy of Talampanel in patients with recurrent malignant glioma as measured by 6-month progression survival, as well as to obtain preliminary information regarding the spectrum of toxicities of the drug among this patient population.
- Conditions
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Oligoastrocytoma
- Being tested
- Talampanel
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalampanelDrug
10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Valproic: 10mg TID week 1, 25mg TID week 2, 35mg week 3 Receives: Drug: Talampanel |
| 2 | Experimental | Non-enzyme-inducing anti-epileptic drugs: 25mg TID week 1, 35mg week 2, 50mg week 3 Receives: Drug: Talampanel |
| 3 | Experimental | Enzyme-inducing anti-epileptic drugs: 35mg TID week 1, 505mg week 2, 75mg week 3 Receives: Drug: Talampanel |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startJul 2003
- Primary completionJan 2006
- Study completionApr 2006
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
- Intervention model
- Parallel groups
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062504
- Sponsor's protocol ID
- IXR-205-21-189
- Status last verified
- May 2011
- First submitted
- 6 Jun 2003
- 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 Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.
- ClinicalTrials.gov ID
- NCT00062504
- Acronym / sponsor ID
- IXR-205-21-189
- Conditions
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Oligoastrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 Jun 2003 (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.
To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.
Detailed description
To determine the efficacy of Talampanel in patients with recurrent malignant glioma as measured by 6-month progression survival, as well as to obtain preliminary information regarding the spectrum of toxicities of the drug among this patient population.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TalampanelValproic: 10mg TID week 1, 25mg TID week 2, 35mg week 3 |
| 2 | Experimental | Drug: TalampanelNon-enzyme-inducing anti-epileptic drugs: 25mg TID week 1, 35mg week 2, 50mg week 3 |
| 3 | Experimental | Drug: TalampanelEnzyme-inducing anti-epileptic drugs: 35mg TID week 1, 505mg week 2, 75mg week 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
- Patients must have unequivocal evidence for tumor progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
- If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated.
- Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
Key exclusion criteria (3 listed)
- Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible that would significantly increase the risk of using talampanel.
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Patients known to have an active, life-threatening malignancy.
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 |
|---|---|---|
| Talampanel10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks | Drug | 1, 2, 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
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 Talampanel in people with Glioblastoma Multiforme and Anaplastic Astrocytoma, 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 20 inclusion and 3 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: stopped early, 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 was stopped early. Results are not available in the source record.
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.
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.