GlioblastomaPhase 1NCT02010606
Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma
A Phase 1 study testing Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy and Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab in people with Glioblastoma and Glioblastoma Multiforme, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and effects of a special type of a cancer vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's own immune system against their tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme, Glioma
- What is being tested?
- Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy and Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2014to 10 Jul 2021
- 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
- Cohort A: Newly diagnosed glioblastoma Patients with an initial biopsy or partial resection can qualify for Cohort A if the second surgery (to achieve gross total resection) occurs within 30 days of the initial surgery, without any interval treatment using radiation or chemotherapy between the two surgeries.
- Cohort B: Glioblastoma up to and including third recurrence To qualify for Cohort B, patients must have previously been treated with involved-field radiation therapy with concurrent temozolomide chemotherapy, and pathology from the resection that qualifies the patient for the trial must be consistent with recurrent disease (ie, patients with predominantly pseudoprogression or radiation necrosis are not eligible). Patients who were initially diagnosed with low-grade glioma (ie, WHO grade 2 glioma) with subsequent progression to high-grade glioma are eligible for Cohort B provided they meet all other eligibility criteria. Patients with recurrent high-grade glioma are eligible up to and including third recurrence, and therefore are permitted to have been treated with up to three distinct chemotherapy regimens prior to trial enrollment. Prior and/or continued bevacizumab therapy is allowed.
- Complete resection of tumor: gross total resection consisting of no gadolinium enhancement or linear gadolinium enhancement along the resection cavity; or subtotal resection consisting of linear enhancement with nodular gadolinium enhancement of less than 1cm x 1cm x 1cm total volume. The qualifying surgical resection must have been performed at Cedars-Sinai in order to allow for tumor stem cell antigen testing.
- ≥ 18 years of age
- Karnofsky Performance Score (KPS) of ≥ 70%
- Baseline hematologic studies and chemistry profiles must meet the following criteria: hemoglobin (Hgb) > 9.9 g/dL, absolute neutrophil count (ANC) > 1000/mm3, platelet count > 100,000/mm3, blood urea nitrogen (BUN) < 30 mg/dL, creatinine < 1.4 mg/dL, alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN), prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
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- Female patients of child bearing potential must have negative serum pregnancy test
- If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
- Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
- Ability to understand and the willingness to sign a written informed consent document.
- Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks to Grade 1 or less
Who cannot join
- Presence of any other active malignancy or prior history of malignancy that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results.
- Clinically significant pulmonary, cardiac or other systemic disease that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results - for example:
- New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry;
- Uncontrolled or significant cardiovascular disease, including:
- Myocardial infarction within 6 months prior to enrollment
- Uncontrolled angina within 6 months
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- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
- Clinically significant abnormality on electrocardiogram (ECG)
- Pulmonary disease including or greater than grade 2 dyspnea, laryngeal edema, grade 3 pulmonary edema, pulmonary hypertension according to CTCAE 4.03
- Severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following: (a) Immunosuppressive disease, (b) Chronic renal disease / failure, (c) Concurrent neurodegenerative disease, (d) Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
- Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
- Active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
- Breastfeeding
- Received any other therapeutic investigational agent within 30 days of enrollment
- Contraindication to MRI
- Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis.
- Any foreseeable scheduling constraint that would prevent a patient in Cohort A from starting chemoradiation within 7 weeks of surgery, and any foreseeable scheduling constraint that would prevent a patient in Cohort B from starting the Vaccine Induction Phase within 7 weeks of surgery.
- Any concomitant chemotherapy other than standard-dose temozolomide for patients in Cohort A; any concomitant chemotherapy for patients in Cohort B, with the exception of the antiangiogenic humanized monoclonal antibody bevacizumab, which is allowed for patients treated with bevacizumab prior to enrollment in the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma
The purpose of this study is to test the safety and effects of a special type of a cancer vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's own immune system against their tumor. This study utilizes a patient's own immune-stimulating dendritic cells that are isolated in a procedure called leukapheresis. In a laboratory, these dendritic cells are treated in a way that is designed to promote an immune response against cancer stem cells. Then the dendritic cells are injected under the skin in a series of vaccinations, with the goal of activating an immune response against cancer stem cells in the tumor.
To qualify for this study, patients must have very little to no residual tumor visible on a recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent glioblastoma will not receive any treatment other than the vaccines as long as they are participating in this study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Read the detailed description
This phase I study for patients with either newly diagnosed or recurrent glioblastoma with minimal residual tumor utilizes a dendritic cell vaccine consisting of autologous dendritic cells that have been pulsed with a lysate derived from an allogeneic glioblastoma stem-like cell line cultured under neurosphere-forming conditions.
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the Induction phase beginning at the conclusion of radiation. Patients with recurrent glioblastoma will not receive treatment other than the investigative treatment, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioma, Astrocytoma, Brain Tumor
- Being tested
- Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy, Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab
- Keywords
- Newly diagnosed glioblastoma, Recurrent glioblastoma, Dendritic cell vaccine, Immunotherapy, Cancer stem cells, Glioma stem cells, Glioma stem-like cells, Cancer stem-like cells, Neurosphere, Therapeutic Uses, Antineoplastic Agents, Neoplasms, Immunologic Factors, Interferon Inducers, Physiological Effects of Drugs, Pharmacologic Actions
- Medical subject headings
- Glioblastoma, Glioma, Astrocytoma, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapyBiological
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the vaccine Induction phase beginning at the conclusion of radiation.
Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumabBiological
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. Patients with recurrent glioblastoma will not receive additional treatment other than the investigative treatment as long as they remain on study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Patients with newly diagnosed glioblastoma | Experimental | Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy Receives: Biological: Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy |
| Cohort B: Patients with recurrent glioblastoma | Experimental | Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab Receives: Biological: Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 4.03
Measured: 1 year
Assess the number of serious adverse events
Measured: 1 year
Assess treatment-related toxicities
We will assess possible vaccine-related adverse effects, including but not limited to cerebral edema, autoimmune reactions, and allergic reactions.
Measured: 1 year
Secondary outcomes (5)
Evaluate Overall Survival (OS) and Progression-Free Survival (PFS)
Measured: 2 years
Evaluate health-related quality of life parameters
Measured: 2 years
Assess the overall response rate, defined as the percentage of patients showing either partial response or complete response, in patients with subtotal resection
Measured: 2 years
Evaluate immune response by assessing cytotoxic T cell activity in vitro pre- vs post-vaccination
Measured: 2 years
Assess tumor stem cell antigen expression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start8 Jan 2014
- Primary completion23 Jan 2019
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jethro Hu, Cedars-Sinai Medical Center
- Investigators
- Jethro Hu, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010606
- Sponsor's protocol ID
- 33203
- Status last verified
- Nov 2021
- First submitted
- 2 Dec 2013
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu JL, Omofoye OA, Rudnick JD, Kim S, Tighiouart M, Phuphanich S, Wang H, Mazer M, Ganaway T, Chu RM, Patil CG, Black KL, Shiao SL, Wang R, Yu JS. A Phase I Study of Autologous Dendritic Cell Vaccine Pulsed with Allogeneic Stem-like Cell Line Lysate in Patients with Newly Diagnosed or Recurrent Glioblastoma. Clin Cancer Res. 2022 Feb 15;28(4):689-696. doi: 10.1158/1078-0432.CCR-21-2867.
PubMed 34862245
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT02010606
- Acronym / sponsor ID
- 33203
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioma, Astrocytoma, Brain Tumor
- Keywords
- Newly diagnosed glioblastoma, Recurrent glioblastoma, Dendritic cell vaccine, Immunotherapy, Cancer stem cells, Glioma stem cells, Glioma stem-like cells, Cancer stem-like cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 8 Jan 2014 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 13 Dec 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.
The purpose of this study is to test the safety and effects of a special type of a cancer vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's own immune system against their tumor. This study utilizes a patient's own immune-stimulating dendritic cells that are isolated in a procedure called leukapheresis. In a laboratory, these dendritic cells are treated in a way that is designed to promote an immune response against cancer stem cells. Then the dendritic cells are injected under the skin in a series of vaccinations, with the goal of activating an immune response against cancer stem cells in the tumor.
To qualify for this study, patients must have very little to no residual tumor visible on a recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent glioblastoma will not receive any treatment other than the vaccines as long as they are participating in this study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Detailed description
This phase I study for patients with either newly diagnosed or recurrent glioblastoma with minimal residual tumor utilizes a dendritic cell vaccine consisting of autologous dendritic cells that have been pulsed with a lysate derived from an allogeneic glioblastoma stem-like cell line cultured under neurosphere-forming conditions.
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the Induction phase beginning at the conclusion of radiation. Patients with recurrent glioblastoma will not receive treatment other than the investigative treatment, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Patients with newly diagnosed glioblastoma | Experimental | Biological: Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapyDendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy |
| Cohort B: Patients with recurrent glioblastoma | Experimental | Biological: Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumabDendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Cohort A: Newly diagnosed glioblastoma Patients with an initial biopsy or partial resection can qualify for Cohort A if the second surgery (to achieve gross total resection) occurs within 30 days of the initial surgery, without any interval treatment using radiation or chemotherapy between the two surgeries.
- Cohort B: Glioblastoma up to and including third recurrence To qualify for Cohort B, patients must have previously been treated with involved-field radiation therapy with concurrent temozolomide chemotherapy, and pathology from the resection that qualifies the patient for the trial must be consistent with recurrent disease (ie, patients with predominantly pseudoprogression or radiation necrosis are not eligible). Patients who were initially diagnosed with low-grade glioma (ie, WHO grade 2 glioma) with subsequent progression to high-grade glioma are eligible for Cohort B provided they meet all other eligibility criteria. Patients with recurrent high-grade glioma are eligible up to and including third recurrence, and therefore are permitted to have been treated with up to three distinct chemotherapy regimens prior to trial enrollment. Prior and/or continued bevacizumab therapy is allowed.
- Complete resection of tumor: gross total resection consisting of no gadolinium enhancement or linear gadolinium enhancement along the resection cavity; or subtotal resection consisting of linear enhancement with nodular gadolinium enhancement of less than 1cm x 1cm x 1cm total volume. The qualifying surgical resection must have been performed at Cedars-Sinai in order to allow for tumor stem cell antigen testing.
- ≥ 18 years of age
- Karnofsky Performance Score (KPS) of ≥ 70%
Key exclusion criteria (20 listed)
- Presence of any other active malignancy or prior history of malignancy that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results.
- Clinically significant pulmonary, cardiac or other systemic disease that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results - for example:
- Pulmonary disease including or greater than grade 2 dyspnea, laryngeal edema, grade 3 pulmonary edema, pulmonary hypertension according to CTCAE 4.03
- Severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following: (a) Immunosuppressive disease, (b) Chronic renal disease / failure, (c) Concurrent neurodegenerative disease, (d) Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
- Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
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 |
|---|---|---|
| Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapyPatients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the vaccine Induction phase beginning at the conclusion of radiation. | Biological | Cohort A: Patients with newly diagnosed glioblastoma |
| Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumabPatients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. Patients with recurrent glioblastoma will not receive additional treatment other than the investigative treatment as long as they remain on study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab | Biological | Cohort B: Patients with recurrent glioblastoma |
Primary outcome
Assess safety and tolerability according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 4.03
Time frame: 1 year
Assess the number of serious adverse events
Time frame: 1 year
Assess treatment-related toxicities
Time frame: 1 year
We will assess possible vaccine-related adverse effects, including but not limited to cerebral edema, autoimmune reactions, and allergic reactions.
5 secondary outcomes
Evaluate Overall Survival (OS) and Progression-Free Survival (PFS)
Time frame: 2 years
Evaluate health-related quality of life parameters
Time frame: 2 years
Assess the overall response rate, defined as the percentage of patients showing either partial response or complete response, in patients with subtotal resection
Time frame: 2 years
Evaluate immune response by assessing cytotoxic T cell activity in vitro pre- vs post-vaccination
Time frame: 2 years
Assess tumor stem cell antigen expression
Time frame: 2 years
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 22 Nov 2021.
- Derived from this study: PubMed 34862245Hu JL, Omofoye OA, Rudnick JD, Kim S, Tighiouart M, Phuphanich S, Wang H, Mazer M, Ganaway T, Chu RM, Patil CG, Black KL, Shiao SL, Wang R, Yu JS. A Phase I Study of Autologous Dendritic Cell Vaccine Pulsed with Allogeneic Stem-like Cell Line Lysate in Patients with Newly Diagnosed or Recurrent Glioblastoma. Clin Cancer Res. 2022 Feb 15;28(4):689-696. doi: 10.1158/1078-0432.CCR-21-2867.
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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.
Jethro Hu, MD principal investigator
Cedars-Sinai Medical Center
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 Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy and Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab in people with Glioblastoma and Glioblastoma Multiforme, run by Cedars-Sinai Medical Center 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 11 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: finished, as of the sponsor's last update on 22 Nov 2021. 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?
Assess safety and tolerability according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 4.03 (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010606, which also lists 1 linked publication.
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 22 Nov 2021.