GlioblastomaPhase 1PERFORMANCENCT01854099
Peptide Vaccine for Glioblastoma Against Cytomegalovirus Antigens
A Phase 1 study testing PEP-CMV in people with Glioblastoma, run by University of Florida.
Trial summary
Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation. Patients will then be randomized to one of three arms: 1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- PEP-CMV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2014
- 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
- Age ≥ 18 years.
- Histopathologically proven newly-diagnosed primary glioblastoma multiforme.
- The tumor must have a supratentorial component.
- Patients must be CMV seropositive.
- Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member or legal representative.
- For females of child-bearing potential, negative serum pregnancy test 48 hours prior to temozolomide.
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- Women of childbearing potential and male participants must practice adequate contraception.
- Karnofsky performance status of ≥ 60.
- Patients must have recovered from the effects of surgery, postoperative infection, and other complications at time of enrollment.
- Prior to adjuvant TMZ:
- Patients must complete radiation therapy (RT) (60.0Gy over 6 weeks) and concomitant TMZ (targeted dose of 75mg/m2/d for <49 days) therapy without significant toxicity that persisted over a duration of 4 weeks. Significant toxicity is defined as one or more of the following observations:
- Absolute neutrophil count (ANC) < 0.5 x 109/L (Grade 4)
- Platelet count < 10 x 109/L (Grade 4)
- Grade 3 or 4 non-hematologic adverse event (AE) (except alopecia, nausea and vomiting unless the patient has failed maximal antiemetic therapy, and fatigue).
- Documentation of stable or decreasing steroid dose prior to randomization with goal of minimizing steroid use.
- CBC/differential with adequate bone marrow function as defined below:
- ANC, ≥ 1500 cells/mm^3. Platelet count, ≥ 100,000 cells/mm^3.
- Hemoglobin ≥ 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
- Adequate renal function prior to vaccination as defined below:
- Blood Urea Nitrogen (BUN) ≤ 25 mg/dl Creatinine ≤ 1.7 mg/dl
- Adequate hepatic function prior to vaccination as defined below:
- Bilirubin ≤ 2.0 mg/dl
- ALT ≤ 3 x normal range
- AST ≤ 3 x normal range
Who cannot join
- Patients did not start RT and TMZ within 5 weeks of surgery.
- Patients that did not complete 60.0Gy over 6-7 weeks of RT (patients consented prior to completion who do not complete RT will be removed from study and replaced).
- Progression of disease prior to randomization as defined by RANO.
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
- Metastases detected below the tentorium or beyond the cranial vault.
- Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region (other than TMZ prescribed during radiation for glioblastoma); note that prior chemotherapy for a different cancer is allowable.
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- Prior radiotherapy to the head or neck (except for T1 glottic cancer and that prescribed for GBM ≤60 Gy), resulting in overlap of radiation fields. Radiosurgery is not permitted.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of beginning chemoradiation.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of beginning chemoradiation.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug.
- Prior allergic reaction to temozolomide or Keyhole Limpet Hemocyanin (KLH).
- Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.
About this study
Official title: Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation. Patients will then be randomized to one of three arms: 1). standard temozolomide (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3). dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ cycles and continue after TMZ cycles until progression or death.
Read the detailed description
Eligible patients will be screened and enrolled prior to completion of post-surgical chemoradiation. Final eligibility to remain on study for safety endpoint will occur after completion of chemoradiation and prior to initiation of adjuvant TMZ regimen. Immediately post-chemoradiation and prior to initiation of cycle 1 of adjuvant TMZ, all patients will receive 500 µg of PEP-CMV vaccine weekly for a total of 3 vaccines starting 1-3 days after chemoradiation is complete. Prior to initiation of TMZ cycle 1, patients will be randomized to one of three arms (1:1:1) to receive (1) standard TMZ (200 mg/m^2/day x 5 days) with vaccination on Day 6-8 of each monthly TMZ cycle, (2) standard TMZ (200 mg/m^2/day x 5 days) with vaccination on Day 22-24 of each monthly TMZ cycle, or (3) dose-intensified TMZ (100 mg/m^2/day x 21 days) with vaccination on day 22-24 of each monthly TMZ cycle. Each cohort will have 20 patients. Up to 150 patients will be consented in order to obtain 60 evaluable patients.
The primary safety assessment for dose-limiting toxicity (DLT) will be determined one week after the third weekly vaccine. A DLT will be defined as any irreversible Grade 3 toxicity, any Grade 4 toxicity, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. Initially 6 patients will be accrued to the study (2 per arm) after which accrual will be suspended to review the toxicity experienced by these patients during the first 3 weekly vaccinations. If 0 or 1 of these patients experience DLT, accrual of the remaining patients will commence. Otherwise, modifications of the protocol will be considered before accruing additional patients.
The prevalence of DLT occurring during the initial 3 weekly vaccinations or the vaccinations administered concurrently with temozolomide will be continuously monitored. If more than 25% of accrued patients experience DLT, then accrual will be suspended and reported toxicity will be carefully reviewed to determine if modifications to the protocol treatment should occur. Peptide vaccinations employing GM-CSF and Montanide ISA-51 as adjuvants have generally been well tolerated in human patients in numerous phase I-III trials.
Treatment Plan: One week after the 3rd weekly vaccination, cycles of TMZ will begin. The start of all subsequent cycles will be scheduled every 4 weeks after the first daily dose of the preceding cycle. During monthly TMZ cycles, vaccinations will occur on day 6-8 or day 22-24 of each cycle, depending on randomization arm. All vaccines will be given i.d. approximately 10cm below the inguinal ligament bilaterally. A target of six cycles with maximum of twelve cycles of TMZ may be given if the patient demonstrates continued improvement on MRI scan, decreased corticosteroid requirement, improvement in performance status, or improvement in neurologic function at the discretion of the treating neuro-oncologist. Vaccines will continue monthly after TMZ cycles until tumor progression or death.
Patients will be imaged with contrast-enhanced MRI pre \& post-surgical resection (prior to initiation of chemoradiation), post-chemoradiation and prior to TMZ cycle 1, prior to TMZ cycle 4, 7 (if administered), and 10 (if administered). MRI imaging every 3 months during post-chemoradiation is preferable, but every 2 months is allowed at the discretion of the treating neuro-oncologist. MRI imaging will be conducted every 3 months after completion of TMZ for 1 year, and then every 6 months thereafter, or at frequency indicated by clinical presentation. The modified Response Assessment in Neuro-Oncology (RANO) criteria will be used for assessment of pseudoprogression and patients demonstrating definitive progression will be removed from study. Any patient removed for definitive tumor progression prior to receiving third vaccine and post vaccination immune monitoring blood draw will be replaced for safety and immunologic endpoints. Clinical endpoint comparisons will be made amongst patients successfully randomized to adjuvant TMZ treatment arms.
Blood for immune monitoring will be obtained prior to vaccines 1-4, 7 and 13, and at tumor progression. Patients seen by the Duke neuro-oncology team between these vaccine visits may have blood drawn for immune monitoring at the discretion of the study team.
As part of standard care for these patients, upon tumor progression, participants may undergo stereotactic biopsy or resection. As this is not a research procedure, consent will be obtained separately. Patients that have this procedure done here at Duke University Health System, may be approached to participate in the Duke Brain Tumor Center Biorepository study. Tissue obtained from patients who consented to the Duke Brain Tumor Center Biorepository will be used to assess immunologic cell infiltration, antigen expression, and biomarkers for immunologic response.
- Conditions
- Glioblastoma
- Being tested
- PEP-CMV
- Keywords
- Brain Tumor
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-CMVBiological
500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 1.
PEP-CMVBiological
500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 2.
PEP-CMVBiological
500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m^2 x 21 days) with group 3.
| Study group | Role | What they receive |
|---|---|---|
| 5 Day TMZ with PEP-CMV on Day 6-8 | Active comparator | Standard TMZ (200 mg/m2/day x 5 days) with PEP-CMV vaccination on Day 6-8 of each monthly TMZ cycle Receives: Biological: PEP-CMV |
| 5 day TMZ with vaccine on day 22-24 | Active comparator | Standard TMZ (200 mg/m2/day x 5 days) with vaccination on Day 22-24 of each monthly TMZ cycle Receives: Biological: PEP-CMV |
| 21 day TMZ wtih vaccine on day 22-24 | Active comparator | Dose-intensified TMZ (100 mg/m2/day x 21 days) with vaccination on day 22-24 of each monthly TMZ cycle Receives: Biological: PEP-CMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To determine the optimal \& safe peptide vaccination regimen with TMZ through dose-limiting toxicity (DLT) measurements. The primary safety assessment for DLT will be determined 1 week after the 3rd weekly vaccine. A DLT will be defined as any irreversible Grade 3 toxicity, any Grade 4 toxicity, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. Initially 6 patients will be accrued to the study (2 per arm) after which accrual will be suspended to review the toxicity experienced by these patients during the first 3 weekly vaccinations. If 0 or 1 of these patients experience DLT, accrual of the remaining patients will commence. Otherwise, modifications of the protocol will be considered before accruing additional patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Investigator decided not to open study.
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.
- More trials run by University of FloridaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Brain Tumor Association
- Responsible party
- Sponsor
- Investigators
- Duane A Mitchell, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854099
- Sponsor's protocol ID
- PERFORMANCE
- Acronym
- PERFORMANCE
- Status last verified
- Jan 2014
- First submitted
- 11 May 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
- ClinicalTrials.gov ID
- NCT01854099
- Acronym / sponsor ID
- PERFORMANCE / PERFORMANCE
- Conditions
- Glioblastoma
- Keywords
- Brain Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided not to open study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Brain Tumor Association
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 May 2013 (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.
Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation. Patients will then be randomized to one of three arms: 1). standard temozolomide (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3). dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ cycles and continue after TMZ cycles until progression or death.
Detailed description
Eligible patients will be screened and enrolled prior to completion of post-surgical chemoradiation. Final eligibility to remain on study for safety endpoint will occur after completion of chemoradiation and prior to initiation of adjuvant TMZ regimen. Immediately post-chemoradiation and prior to initiation of cycle 1 of adjuvant TMZ, all patients will receive 500 µg of PEP-CMV vaccine weekly for a total of 3 vaccines starting 1-3 days after chemoradiation is complete. Prior to initiation of TMZ cycle 1, patients will be randomized to one of three arms (1:1:1) to receive (1) standard TMZ (200 mg/m^2/day x 5 days) with vaccination on Day 6-8 of each monthly TMZ cycle, (2) standard TMZ (200 mg/m^2/day x 5 days) with vaccination on Day 22-24 of each monthly TMZ cycle, or (3) dose-intensified TMZ (100 mg/m^2/day x 21 days) with vaccination on day 22-24 of each monthly TMZ cycle. Each cohort will have 20 patients. Up to 150 patients will be consented in order to obtain 60 evaluable patients.
The primary safety assessment for dose-limiting toxicity (DLT) will be determined one week after the third weekly vaccine. A DLT will be defined as any irreversible Grade 3 toxicity, any Grade 4 toxicity, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. Initially 6 patients will be accrued to the study (2 per arm) after which accrual will be suspended to review the toxicity experienced by these patients during the first 3 weekly vaccinations. If 0 or 1 of these patients experience DLT, accrual of the remaining patients will commence. Otherwise, modifications of the protocol will be considered before accruing additional patients.
The prevalence of DLT occurring during the initial 3 weekly vaccinations or the vaccinations administered concurrently with temozolomide will be continuously monitored. If more than 25% of accrued patients experience DLT, then accrual will be suspended and reported toxicity will be carefully reviewed to determine if modifications to the protocol treatment should occur. Peptide vaccinations employing GM-CSF and Montanide ISA-51 as adjuvants have generally been well tolerated in human patients in numerous phase I-III trials.
Treatment Plan: One week after the 3rd weekly vaccination, cycles of TMZ will begin. The start of all subsequent cycles will be scheduled every 4 weeks after the first daily dose of the preceding cycle. During monthly TMZ cycles, vaccinations will occur on day 6-8 or day 22-24 of each cycle, depending on randomization arm. All vaccines will be given i.d. approximately 10cm below the inguinal ligament bilaterally. A target of six cycles with maximum of twelve cycles of TMZ may be given if the patient demonstrates continued improvement on MRI scan, decreased corticosteroid requirement, improvement in performance status, or improvement in neurologic function at the discretion of the treating neuro-oncologist. Vaccines will continue monthly after TMZ cycles until tumor progression or death.
Patients will be imaged with contrast-enhanced MRI pre \& post-surgical resection (prior to initiation of chemoradiation), post-chemoradiation and prior to TMZ cycle 1, prior to TMZ cycle 4, 7 (if administered), and 10 (if administered). MRI imaging every 3 months during post-chemoradiation is preferable, but every 2 months is allowed at the discretion of the treating neuro-oncologist. MRI imaging will be conducted every 3 months after completion of TMZ for 1 year, and then every 6 months thereafter, or at frequency indicated by clinical presentation. The modified Response Assessment in Neuro-Oncology (RANO) criteria will be used for assessment of pseudoprogression and patients demonstrating definitive progression will be removed from study. Any patient removed for definitive tumor progression prior to receiving third vaccine and post vaccination immune monitoring blood draw will be replaced for safety and immunologic endpoints. Clinical endpoint comparisons will be made amongst patients successfully randomized to adjuvant TMZ treatment arms.
Blood for immune monitoring will be obtained prior to vaccines 1-4, 7 and 13, and at tumor progression. Patients seen by the Duke neuro-oncology team between these vaccine visits may have blood drawn for immune monitoring at the discretion of the study team.
As part of standard care for these patients, upon tumor progression, participants may undergo stereotactic biopsy or resection. As this is not a research procedure, consent will be obtained separately. Patients that have this procedure done here at Duke University Health System, may be approached to participate in the Duke Brain Tumor Center Biorepository study. Tissue obtained from patients who consented to the Duke Brain Tumor Center Biorepository will be used to assess immunologic cell infiltration, antigen expression, and biomarkers for immunologic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 Day TMZ with PEP-CMV on Day 6-8 | Active comparator | Biological: PEP-CMVStandard TMZ (200 mg/m2/day x 5 days) with PEP-CMV vaccination on Day 6-8 of each monthly TMZ cycle |
| 5 day TMZ with vaccine on day 22-24 | Active comparator | Biological: PEP-CMVStandard TMZ (200 mg/m2/day x 5 days) with vaccination on Day 22-24 of each monthly TMZ cycle |
| 21 day TMZ wtih vaccine on day 22-24 | Active comparator | Biological: PEP-CMVDose-intensified TMZ (100 mg/m2/day x 21 days) with vaccination on day 22-24 of each monthly TMZ cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years.
- Histopathologically proven newly-diagnosed primary glioblastoma multiforme.
- The tumor must have a supratentorial component.
- Patients must be CMV seropositive.
- Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member or legal representative.
Key exclusion criteria (20 listed)
- Patients did not start RT and TMZ within 5 weeks of surgery.
- Patients that did not complete 60.0Gy over 6-7 weeks of RT (patients consented prior to completion who do not complete RT will be removed from study and replaced).
- Progression of disease prior to randomization as defined by RANO.
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
- Metastases detected below the tentorium or beyond the cranial vault.
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 |
|---|---|---|
| PEP-CMV500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 1. | Biological | 5 Day TMZ with PEP-CMV on Day 6-8 |
| PEP-CMV500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 2. | Biological | 5 day TMZ with vaccine on day 22-24 |
| PEP-CMV500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m^2 x 21 days) with group 3. | Biological | 21 day TMZ wtih vaccine on day 22-24 |
Primary outcome
Safety
Time frame: 6 months
To determine the optimal \& safe peptide vaccination regimen with TMZ through dose-limiting toxicity (DLT) measurements. The primary safety assessment for DLT will be determined 1 week after the 3rd weekly vaccine. A DLT will be defined as any irreversible Grade 3 toxicity, any Grade 4 toxicity, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. Initially 6 patients will be accrued to the study (2 per arm) after which accrual will be suspended to review the toxicity experienced by these patients during the first 3 weekly vaccinations. If 0 or 1 of these patients experience DLT, accrual of the remaining patients will commence. Otherwise, modifications of the protocol will be considered before accruing additional patients.
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 14 Jan 2014.
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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.
Duane A Mitchell, MD, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP-CMV in people with Glioblastoma, run by University of Florida.
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 24 inclusion and 20 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 14 Jan 2014. 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 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: 6 months). 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 14 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.