Brain CancerPhase 1NCT00185861
Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma
A Phase 1 study testing Arsenic Trioxide and Stereotactic radiosurgery in people with Brain Cancer, run by Stanford University at 1 site in United States.
Trial summary
To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I dose escalation trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Arsenic Trioxide and Stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Apr 2009
- 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
- Evidence of recurrent disease.
- All patients will have received previous conventional radiotherapy at least 3 weeks prior to enrollment. Histologic verification of malignant glioma is required. If the initial primary brain tumor was histologically malignant glioma and subsequent contrast enhanced MRI imaging shows tumor consistent with recurrence, additional biopsy or surgery is not required. However, if a low-grade neoplasm was the initial histologic diagnosis, tissue confirmation of malignant glioma is required at the time of recurrence.
- Age: Patients must be >18 years of age
- Patients must have a Karnofsky >60%, and/or ECOG performance status <2
- Patients must have an estimated life expectancy of greater than 8 weeks.
- Patients must have normal organ and marrow functions as defined below:
Show all 32Show fewer
- Leukocytes >3,000/¼l
- Absolute neutrophil count >1,500/¼l
- Hemoglobin > 10 gm/dl
- Platelets >100,000/¼l (transfusion independent)
- Total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) <1.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR
- Creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Serum potassium* e 4.0mEq/L
- Serum magnesium* e 1.8mEq/L
- Serum calcium* within the institutional normal range (should be corrected if low normal)
- Electrocardiogram Normal
- electrocardiogram with a rate corrected QT interval (QTc) <500 msec
- Oral or intravenous supplementation may be used to normalize serum electrolytes
- Phase I ATO Stereotactic Radiotherapy for Recurrent Malignant Glioma 16 of 44
- Informed consent All patients or their legal guardians must sign a document of informed consent indicating their understanding of the investigational nature of this study and the risks involved prior to any protocol related are performed (which does not include imaging and laboratory studies that help to establish eligibility).
- Exclusion Criteria:- Patients who have had chemotherapy or conventional radiotherapy within 3 weeks of enrollment.
- Patients who have received prior radiosurgery or stereotactic radiotherapy within 10mm of the current target tumor.
- Patients may not be receiving any other investigational agents.
- Patients who cannot undergo MRI or CT are not eligible as MRI will be used to confirm the diagnosis and CT will be used for treatment planning.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to arsenic trioxide or other agents used in study.
- Patients who are taking substances known to prolong the QT interval, see Appendix B. If the QT prolonging drug is discontinued and switched to an alternative agent, the patients will be allowed to enroll into this protocol as long the agent has been discontinued for a period of at least 2 weeks.
- Patients currently taking Amphotericin B or related antifungal agents will be excluded due to potential for increased renal electrolyte wasting during arsenic trioxide therapy.
- Patients with known second-degree heart block or other cardiac dysfunction. New York Heart Association Class II or greater (see Appendix E)
- Uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. Phase I ATO Stereotactic Radiotherapy for Recurrent Malignant Glioma 17 of 44
- Patients must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Patients who are pregnant or breast-feeding will be excluded because no information on this agent exists with regard to safety of arsenic trioxide for a fetus or breast-feeding infant. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I dose escalation trial. Results from this study will provide a basis for further study of ATO combined with radiation therapy as a radiosensitizer for malignant brain tumors in future Phase II studies.
- Conditions
- Brain Cancer
- Being tested
- Arsenic Trioxide, Stereotactic radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
Stereotactic radiosurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe and define toxicities of ATO combined with radiotherapy in patients with recurrent malignant glioma.
Define the maximum tolerated dose (MTD) of ATO combined with stereotactic radiotherapy for recurrent malignant glioma.
Secondary outcomes (3)
Evaluate time to progression and survival
Evaluate radiographic tumor response rate
Determine the recommended dose for investigation in a Phase II study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJan 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon, CTI BioPharma
- Investigators
- Iris Catrice Gibbs, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185861
- Sponsor's protocol ID
- BRNCNS0001
- Other IDs
- 79756, BRNCNS0001, NCT00185861
- Status last verified
- Apr 2009
- First submitted
- 12 Sep 2005
- Last updated
- 9 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma
- ClinicalTrials.gov ID
- NCT00185861
- Acronym / sponsor ID
- BRNCNS0001
- Conditions
- Brain Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Cephalon, CTI BioPharma
- Study start
- Dec 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Sep 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.
To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I dose escalation trial. Results from this study will provide a basis for further study of ATO combined with radiation therapy as a radiosensitizer for malignant brain tumors in future Phase II studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Evidence of recurrent disease.
- All patients will have received previous conventional radiotherapy at least 3 weeks prior to enrollment. Histologic verification of malignant glioma is required. If the initial primary brain tumor was histologically malignant glioma and subsequent contrast enhanced MRI imaging shows tumor consistent with recurrence, additional biopsy or surgery is not required. However, if a low-grade neoplasm was the initial histologic diagnosis, tissue confirmation of malignant glioma is required at the time of recurrence.
- Age: Patients must be >18 years of age
- Patients must have a Karnofsky >60%, and/or ECOG performance status <2
- Patients must have an estimated life expectancy of greater than 8 weeks.
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 |
|---|---|---|
| Arsenic Trioxide | Drug | – |
| Stereotactic radiosurgery | Procedure or surgery | – |
Primary outcome
Describe and define toxicities of ATO combined with radiotherapy in patients with recurrent malignant glioma.
Define the maximum tolerated dose (MTD) of ATO combined with stereotactic radiotherapy for recurrent malignant glioma.
3 secondary outcomes
Evaluate time to progression and survival
Evaluate radiographic tumor response rate
Determine the recommended dose for investigation in a Phase II study
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 9 Apr 2009.
Related trials for Brain Cancer
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Iris Catrice Gibbs principal investigator
Stanford 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 Arsenic Trioxide and Stereotactic radiosurgery in people with Brain Cancer, run by Stanford University 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 32 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 9 Apr 2009. 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?
Describe and define toxicities of ATO combined with radiotherapy in patients with recurrent malignant glioma.. The study lists 2 primary outcomes in all. 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 9 Apr 2009.