Intracranial NeoplasmsPhase 1NCT00247403
Safety Study of 2DG With Stereotactic Radiosurgery
A Phase 1 study testing 2-deoxyglucose (2DG) in people with Intracranial Neoplasms and Neoplasm Metastasis, run by University of Iowa at 1 site in United States.
Trial summary
Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells are preferentially affected by ROS. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intracranial Neoplasms, Neoplasm Metastasis
- What is being tested?
- 2-deoxyglucose (2DG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Brain metastases from histologically confirmed extracranial cancer or previously confirmed intracranial carcinoma. Carcinoma must be staged using the American Joint Committee on Cancer (AJCC) staging criteria version 6.
- Morphologically well-defined tumor mass on computed tomography (CT)/magnetic resonance imaging [MRI] (largest diameter less than 40 mm) after resection.
- Intracranial mass or masses ≤ 4 cm in greatest diameter. Patients with multiple masses will be eligible if their radiosurgery treatment time is expected to last less than one hour (typically a maximum of 6 lesions).
- Standard institutional radiotherapeutic treatment is stereotactic radiosurgery delivered using bite-plate localization.
- Greater than or equal to 21 years of age. Pediatric subjects represent a minority of patients who otherwise meet the eligibility criteria. Inclusion of children in a different study would be considered if therapy is found to be effective in adults and not as part of this trial because the safety of 2DG in children has not been investigated.
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- Karnofsky greater than or equal to 70% at time of screening
- Life expectancy of greater than 3 months
- Subjects must have normal organ and marrow function as defined below:
- serum glucose < 200 mg/dl
- hemoglobin A1C (HbA1c) < 8.5 %
- Contraceptive use in men and women of childbearing potential prior to, and for the duration of, this study. The teratogenic effects of ionizing radiation are well documented, and 2DG has the potential for teratogenic or abortifacient effects.
- Nursing of infants must be suspended during the study. There is an unknown but potential risk for adverse events in infants nursing from patients treated with 2DG, therefore breastfeeding must be discontinued for the duration of the study.
- Ability to ingest 50 ml of fluid either by mouth or feeding tube.
- Inclusion of women and minorities: Both men and women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Subjects with diabetes mellitus, elevated HbA1c or elevated blood glucose.
- Subjects requiring a headring ('halo') immobilization for standard stereotactic localization. Patients with metastases adjacent to optic chiasm, optic nerve or other radiosensitive tissue necessitating the accuracy of a headring will be excluded.
- Subjects must not be receiving any other investigational agents.
- Subjects with a history of myocardial infarction in the past year and/or dependent on beta-adrenergic blocking agents.
- Subjects with an uncontrolled seizure disorder.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing mother with 2DG, breastfeeding must be discontinued while the nursing mother is treated.
- Pregnant women are excluded from this study. The teratogenic effects of ionizing radiation are well documented, and 2DG has the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative pregnancy test result immediately prior to the study and should they become pregnant or suspect that they are pregnant during the study, they must inform their treating physicians immediately.
- Inclusion of prisoners and other vulnerable populations: Prisoners and other vulnerable populations, such as children, will not be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases
Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells are preferentially affected by ROS. The investigators, therefore, propose that interfering with the detoxification of ROS will make radiation more toxic to cancer cells. Several cellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role in many of these mechanisms. The investigators propose that interfering with glucose metabolism will sensitize cancer cells to radiation.
The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizing radiation by inhibiting the use of glucose to detoxify reactive oxygen species produced by radiation. As an initial step to evaluate this hypothesis, the investigators have designed this phase I study.
Read the detailed description
Radiosurgery is a proven treatment option for intracranial metastases. This trial is an initial effort to potentiate the therapeutic effect of single dose stereotactic radiosurgery by combining a radiation sensitizing agent, 2DG, with radiosurgery in the treatment of intracranial metastases. Our preclinical studies indicate the degree of cancer cell radiosensitization using 2DG increases with increasing radiation dose. We therefore are interested to use 2DG with radiosurgery, since this technique allows for delivery of a large single dose of radiation.
This trial seeks to determine the maximum tolerable one time dose of 2DG that can be delivered to subjects receiving stereotactic radiosurgery. We will also measure the physiologic effects of 2DG on glucose and reactive oxygen species metabolism.
- Conditions
- Intracranial Neoplasms, Neoplasm Metastasis
- Being tested
- 2-deoxyglucose (2DG)
- Keywords
- Intracranial cancer, Cancer, 2DG, 2-deoxyglucose, Intracranial metastatic cancer
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-deoxyglucose (2DG)Drug
Addition of 2DG to stereotactic radiosurgery. Dose escalation study.
| Study group | Role | What they receive |
|---|---|---|
| 2DG | Experimental | Not described Receives: Drug: 2-deoxyglucose (2DG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: During treatment and 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Why it stopped: Pharmaceutical company no longer manufactures drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Buatti, University of Iowa
- Investigators
- John M. Buatti, M.D., Principal investigator, University of Iowa Hospitals & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247403
- Sponsor's protocol ID
- 200506744
- Status last verified
- Apr 2015
- First submitted
- 28 Oct 2005
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases
- ClinicalTrials.gov ID
- NCT00247403
- Acronym / sponsor ID
- 200506744
- Conditions
- Intracranial Neoplasms, Neoplasm Metastasis
- Keywords
- Intracranial cancer, Cancer, 2DG, 2-deoxyglucose, Intracranial metastatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pharmaceutical company no longer manufactures drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 1 Nov 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.
Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells are preferentially affected by ROS. The investigators, therefore, propose that interfering with the detoxification of ROS will make radiation more toxic to cancer cells. Several cellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role in many of these mechanisms. The investigators propose that interfering with glucose metabolism will sensitize cancer cells to radiation.
The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizing radiation by inhibiting the use of glucose to detoxify reactive oxygen species produced by radiation. As an initial step to evaluate this hypothesis, the investigators have designed this phase I study.
Detailed description
Radiosurgery is a proven treatment option for intracranial metastases. This trial is an initial effort to potentiate the therapeutic effect of single dose stereotactic radiosurgery by combining a radiation sensitizing agent, 2DG, with radiosurgery in the treatment of intracranial metastases. Our preclinical studies indicate the degree of cancer cell radiosensitization using 2DG increases with increasing radiation dose. We therefore are interested to use 2DG with radiosurgery, since this technique allows for delivery of a large single dose of radiation.
This trial seeks to determine the maximum tolerable one time dose of 2DG that can be delivered to subjects receiving stereotactic radiosurgery. We will also measure the physiologic effects of 2DG on glucose and reactive oxygen species metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2DG | Experimental | Drug: 2-deoxyglucose (2DG) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Brain metastases from histologically confirmed extracranial cancer or previously confirmed intracranial carcinoma. Carcinoma must be staged using the American Joint Committee on Cancer (AJCC) staging criteria version 6.
- Morphologically well-defined tumor mass on computed tomography (CT)/magnetic resonance imaging [MRI] (largest diameter less than 40 mm) after resection.
- Intracranial mass or masses ≤ 4 cm in greatest diameter. Patients with multiple masses will be eligible if their radiosurgery treatment time is expected to last less than one hour (typically a maximum of 6 lesions).
- Standard institutional radiotherapeutic treatment is stereotactic radiosurgery delivered using bite-plate localization.
Key exclusion criteria (9 listed)
- Subjects with diabetes mellitus, elevated HbA1c or elevated blood glucose.
- Subjects requiring a headring ('halo') immobilization for standard stereotactic localization. Patients with metastases adjacent to optic chiasm, optic nerve or other radiosensitive tissue necessitating the accuracy of a headring will be excluded.
- Subjects must not be receiving any other investigational agents.
- Subjects with a history of myocardial infarction in the past year and/or dependent on beta-adrenergic blocking agents.
- Subjects with an uncontrolled seizure disorder.
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 |
|---|---|---|
| 2-deoxyglucose (2DG)Addition of 2DG to stereotactic radiosurgery. Dose escalation study. | Drug | 2DG |
Primary outcome
Safety
Time frame: During treatment and 30 days post-treatment
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 10 Apr 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.
John M. Buatti, M.D. principal investigator
University of Iowa Hospitals & Clinics
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 2-deoxyglucose (2DG) in people with Intracranial Neoplasms and Neoplasm Metastasis, run by University of Iowa 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 15 inclusion and 9 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 10 Apr 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 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?
Safety (time frame: During treatment and 30 days post-treatment). 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 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.