Adult Giant Cell GlioblastomaPhase 1NCT00004262
Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
A Phase 1 study testing conventional surgery, 3-dimensional conformal radiation therapy and stereotactic radiosurgery in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
- What is being tested?
- conventional surgery, 3-dimensional conformal radiation therapy and stereotactic radiosurgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to May 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection
- Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery
- Tumor must be at least 1.0 cm from the optic chiasm and brainstem
- No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas
- No infratentorial tumors
- No multifocal glioblastoma multiforme
Show all 31Show fewer
- Tumor enhances on MRI
- Must have visible tumor on postoperative MRI following surgical resection
- Performance status - Karnofsky 60-100%
- At least 3 months
- Hemoglobin at least 10.0 g/dL
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGPT no greater than 60 U/L
- Creatinine no greater than 1.3 mg/dL
- Blood urea nitrogen no greater than 24 mg/dL
- Neurological function status 0-3
- No evidence of neuropathy
- No glucose-6-phosphate dehydrogenase deficiency
- No known history of porphyria
- History of prior malignancies allowed
- HIV positive status allowed
- No medical contraindication to MRI imaging (i.e., pacemaker, aneurysm clip, or nonsecure metal fragment close to a critical structure)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during study
- At least 6 weeks since prior chemotherapy
- Concurrent steroids allowed
- No prior radiotherapy to the brain or upper neck
- No greater than 5 weeks since prior surgery and recovered
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery.
II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
III. Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients.
OUTLINE: This is a dose escalation study.
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed monthly for 3 months, and then every 3 months for 5 years or until death.
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.
- Being tested
- conventional surgery, 3-dimensional conformal radiation therapy, stereotactic radiosurgery, motexafin gadolinium, magnetic resonance imaging
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Also called surgery, conventional
3-dimensional conformal radiation therapyRadiation
Also called 3D conformal radiation therapy, 3D-CRT
stereotactic radiosurgeryRadiation
motexafin gadoliniumDrug
Also called gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120
Given IV
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets
spectroscopyProcedure or surgery
Undergo plasma-atomic emission spectroscopy (DCP-AES)
| Study group | Role | What they receive |
|---|---|---|
| Treatment (motexafin gadolinium, radiotherapy, radiosurgery) | Experimental | Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery. Receives: Procedure: conventional surgery; Radiation: 3-dimensional conformal radiation therapy; Radiation: stereotactic radiosurgery; Drug: motexafin gadolinium; Procedure: magnetic resonance imaging; Procedure: spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
Measured: At the time of stereotactic radiosurgery
Secondary outcomes (1)
Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry
Measured: At baseline, at 48 hours, and at 2 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1999
- Primary completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Giant Cell GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Grecula, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004262
- Sponsor's protocol ID
- NCI-2012-01400
- Other IDs
- 99H0239, CDR0000067517, NCI-T99-0041, OSU-9976, OSU-99H0239, U01CA076576
- Status last verified
- Jun 2013
- First submitted
- 28 Jan 2000
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
- ClinicalTrials.gov ID
- NCT00004262
- Acronym / sponsor ID
- NCI-2012-01400
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 1999
- Primary completion
- May 2005 (actual)
- First posted
- 27 Jan 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.
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.
Detailed description
PRIMARY OBJECTIVES:
- Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery.
II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
III. Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients.
OUTLINE: This is a dose escalation study.
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed monthly for 3 months, and then every 3 months for 5 years or until death.
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (motexafin gadolinium, radiotherapy, radiosurgery) | Experimental | Procedure: conventional surgery, Radiation: 3-dimensional conformal radiation therapy, Radiation: stereotactic radiosurgery, Drug: motexafin gadolinium, Procedure: magnetic resonance imaging, Procedure: spectroscopyWithin 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection
- Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery
- Tumor must be at least 1.0 cm from the optic chiasm and brainstem
- No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas
- No infratentorial tumors
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| conventional surgeryAlso: surgery, conventional | Procedure or surgery | Treatment (motexafin gadolinium, radiotherapy, radiosurgery) |
| 3-dimensional conformal radiation therapyAlso: 3D conformal radiation therapy, 3D-CRT | Radiation | Treatment (motexafin gadolinium, radiotherapy, radiosurgery) |
| stereotactic radiosurgery | Radiation | Treatment (motexafin gadolinium, radiotherapy, radiosurgery) |
| motexafin gadoliniumAlso: gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120Given IV | Drug | Treatment (motexafin gadolinium, radiotherapy, radiosurgery) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets | Procedure or surgery | Treatment (motexafin gadolinium, radiotherapy, radiosurgery) |
| spectroscopyUndergo plasma-atomic emission spectroscopy (DCP-AES) | Procedure or surgery | Treatment (motexafin gadolinium, radiotherapy, radiosurgery) |
Primary outcome
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
Time frame: At the time of stereotactic radiosurgery
1 secondary outcome
Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry
Time frame: At baseline, at 48 hours, and at 2 weeks post-surgery
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 4 Jun 2013.
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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.
John Grecula principal investigator
Ohio State University
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 conventional surgery, 3-dimensional conformal radiation therapy and stereotactic radiosurgery in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) 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 31 inclusion and 0 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 4 Jun 2013. 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?
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0 (time frame: At the time of stereotactic radiosurgery). 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 4 Jun 2013.