GlioblastomaPhase 1NCT02092038
Preoperative Chemoradiation for Glioblastoma
A Phase 1 study testing Temozolomide, partial brain irradiation and stereotactic biopsy of brain tumor in people with Glioblastoma, run by Tampa General Hospital at 1 site in United States.
Trial summary
Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide, partial brain irradiation and stereotactic biopsy of brain tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2015
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)
- WHO performance status 0-2 (to allow comparison to historical controls)
- Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)
- Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)
- Able to have MRI scans (secondary endpoint is MRI scan characteristics)
- Willing to have radiation treatment at a participating center (homogeneity of treatment parameters)
- Ages 18-80
Who cannot join
- Unresectable tumor
- Absolute neutrophil count (ANC) less than 1,200/μL
- Hemoglobin less than 9.0g/dL
- Platelet count less than 100,000/μL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
Read the detailed description
Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.
Imaging:
MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery.
MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide, partial brain irradiation, stereotactic biopsy of brain tumor, craniotomy and tumor resection
- Keywords
- glioblastoma, temozolomide, radiation therapy, radiotherapy, surgery, pre-operative, neoadjuvant
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
partial brain irradiationRadiation
Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
stereotactic biopsy of brain tumorProcedure or surgery
will be assessed for tumor type and tumor markers
craniotomy and tumor resectionProcedure or surgery
maximal safe resection
| Study group | Role | What they receive |
|---|---|---|
| Preoperative chemoradiation | Experimental | Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide Receives: Drug: Temozolomide; Radiation: partial brain irradiation; Procedure: stereotactic biopsy of brain tumor; Procedure: craniotomy and tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
comparison of toxicity related to experimental treatment to historical local controls
Measured: up to up to 16 weeks
Secondary outcomes (3)
Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples
determination of the feasibility of using standard MGMT activity measurement techniques on stereotactic specimens and comparison of the results with the results from the full resection.
Measured: at enrollment
progression free survival
Measured: up to 12 months
overall survival
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Berk, MD, PhD, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092038
- Sponsor's protocol ID
- TGH0001
- Status last verified
- Nov 2015
- First submitted
- 11 Mar 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
- ClinicalTrials.gov ID
- NCT02092038
- Acronym / sponsor ID
- TGH0001
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, temozolomide, radiation therapy, radiotherapy, surgery, pre-operative, neoadjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Mar 2014 (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.
Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
Detailed description
Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.
Imaging:
MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery.
MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative chemoradiation | Experimental | Drug: Temozolomide, Radiation: partial brain irradiation, Procedure: stereotactic biopsy of brain tumor, Procedure: craniotomy and tumor resectionStereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)
- WHO performance status 0-2 (to allow comparison to historical controls)
- Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)
- Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)
- Able to have MRI scans (secondary endpoint is MRI scan characteristics)
Key exclusion criteria (4 listed)
- Unresectable tumor
- Absolute neutrophil count (ANC) less than 1,200/μL
- Hemoglobin less than 9.0g/dL
- Platelet count less than 100,000/μL
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 |
|---|---|---|
| TemozolomideAlso: TemodarNeoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide. | Drug | Preoperative chemoradiation |
| partial brain irradiationNeoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide. | Radiation | Preoperative chemoradiation |
| stereotactic biopsy of brain tumorwill be assessed for tumor type and tumor markers | Procedure or surgery | Preoperative chemoradiation |
| craniotomy and tumor resectionmaximal safe resection | Procedure or surgery | Preoperative chemoradiation |
Primary outcome
toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
Time frame: up to up to 16 weeks
comparison of toxicity related to experimental treatment to historical local controls
3 secondary outcomes
Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples
Time frame: at enrollment
progression free survival
Time frame: up to 12 months
overall survival
Time frame: up to 12 months
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 10 Nov 2015.
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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.
Lawrence Berk, MD, PhD principal investigator
Tampa General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temozolomide, partial brain irradiation and stereotactic biopsy of brain tumor in people with Glioblastoma, run by Tampa General Hospital at 1 site in United States.
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 7 inclusion and 4 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0 (time frame: up to up to 16 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 10 Nov 2015.