Ewings SarcomaPhase 1NCT01061840
Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer
A Phase 1 study testing Vigil™ in people with Ewings Sarcoma and Non Small Cell Lung Cancer, run by Gradalis, Inc. at 4 sites in United States.
Trial summary
Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the site of intradermal injection and promoting antigen presentation. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ewings Sarcoma, Non Small Cell Lung Cancer, Liver Cancer
- What is being tested?
- Vigil™
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2009to Jan 2019
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion may not be a candidate for curative surgery or radiation therapy). Successful vaccine manufacture has resulted from tissue/fluid obtained from the following major organ systems: digestive, endocrine, reproductive, respiratory, and urinary.Individuals manufactured under CL-PTL 105 (Phase II Ovarian) may be eligible for enrollment without advanced or metastatic disease.
- Patients with well differentiated thyroid cancer are eligible for protocol as follows:
- Surgically unresectable locally recurrent disease and/or metastatic disease following RAI ablation (if locally recurrent and ultrasound (US) positive, baseline FDG-PET or MRI will be obtained).
- Patients with microscopic and/or gross extra thyroidal disease extension without RAI uptake but with a) FDG-PET positive disease or b) suppressed thyroglobulin >1 ng/mL or c) stimulated thyroglobulin >10 ng/L.
- Patients with tracheal/esophageal involvement. High mitotic activity or necrosis in pathology does not exclude from the study.
- Note: in Categories a and b, patients can be followed using US locally in addition to standard diagnostic followup menu but, if US only is positive, a FDG-PET or MRI will be obtained. If negative, a rising thyroglobulin titer is required in which case response will be monitored by continued US and suppressed and/or stimulated thyroglobulin. Thyroglobulin titer cannot be used if anti-thyroglobulin antibodies are present).
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- Completed all acceptable therapies with curative intent that are the current standard of care for their respective diseases. If no conventional therapy available, patient may participate after review by sponsor.
- Recovered from all clinically relevant toxicities related to prior therapies
- Patients will be allowed to participate following single prior CNS treatment with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ≥2 months or following ≥2 prior CNS treatments with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ≥4 months.
- For ESFT patients age ≥12 years.
- Age ≥18 years (non-ESFT candidates)
- ECOG performance status (PS) 0-1.Pediatric patients with Lansky or Karnofsky Performance Status Scale ≥ of 50%.
- Estimated >4 month survival probability.
- Normal organ and marrow function as defined below:
- Absolute granulocyte count ≥ 1,500/mm3 Absolute lymphocyte count ≥ 500/mm3 Platelets ≥ 100,000/mm3 Total bilirubin ≤2 mg/dL AST(SGOT)/ALT(SGPT) <2x institutional upper limit of normal Creatinine <1.5 mg/dL
- Ability to understand and the willingness to sign a written informed consent document. Pediatric patients must sign an assent with a parent or legal guardian sign a written informed consent.
- Negative pregnancy test.
- Patients must be off all "statin" drugs for ≥2 weeks prior to initiation of therapy.
Who cannot join
- Surgery involving general anesthesia, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to entering the study. Palliative radiotherapy is allowable. Collection of lumenal tissue for vaccine manufacture must be avoided.
- Patients must not have received any other investigational agents within 30 days prior to vaccination.
- Concurrent tumor-specific hormonal therapy or antiestrogens. (Individuals manufactured under CL-PTL 105 (Phase II Ovarian) are not subject to this exclusion).
- Patients with known active or symptomatic brain metastases prior to vaccination.
- Patients with compromised pulmonary disease.
- Short term (<30 days) concurrent systemic steroids ≤0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded while receiving vaccine. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.
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- Prior splenectomy unless Howell-Jolly bodies are absent.
- Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for 2 years.
- Kaposi's Sarcoma.
- 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.
- Patients who are pregnant or nursing.
- Patients with known HIV.
- Patients with chronic Hepatitis B and C infection. For patients with hepatocellular carcinoma (HCC), the presence of chronic HBV and HCV is NOT an exclusion. Patients must have a viral titer <50 IU/ml x 2 at a minimum of 2 weeks apart.
- Patients with uncontrolled autoimmune diseases.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Cancer Care Northwest
Spokane, Washington, 99202
Florida Cancer Specialists
West Palm Beach, Florida, 33401
About this study
Official title: Phase I Trial of Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer
Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the site of intradermal injection and promoting antigen presentation. The furin bifunctional shRNA blocks furin protein production at the post transcriptional and translational levels. This decrease in furin in turn decreases the conversion of the proforms TGFβ1 and TGFβ2 proteins. Also, reduced furin protein levels have a negative feedback inhibition on TGFβ1 and TGFβ2 gene expression, decreasing the levels of their mRNAs. The resulting decrease in TGFβ1 and TGFβ2 proteins reduces the local immunosuppression they cause and promotes tumor surface antigen and MHC protein display.
Read the detailed description
Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, we have designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance. We have completed clinical investigations using two different gene vaccine approaches to induce enhancement of tumor antigen recognition which have demonstrated therapeutic efficacy. Specifically, both the use of a GMCSF gene transduced vaccine (GVAX®) and a TGFβ2 antisense gene vaccine (Lucanix®), in separate trials, have demonstrated similar beneficial effects without any evidence of significant toxicity in advanced cancer patients. The GMCSF transgene directly stimulates increased expression of tumor antigen(s) and enhances dendritic cell migration to the vaccination site. TGFβ2 blockade following intracellular TGFβ2 antisense gene expression reduces production of immune inhibiting activity at the vaccine site. This appears to be one of the primary mechanisms of inhibition of immune responsiveness in glioblastoma and lung cancer. In a subsequent Phase I trial we combined both active principles in one autologous vaccine, TAG. TAG vaccine has an excellent safety profile in the first nineteen patients treated (enrollment open to any solid tumor) with one documented CR (melanoma). However, TGFβ1 is the dominant TGFβ family inhibitory effector in the majority of other solid tumors. We describe a unique method of inhibiting both TGFβ1 and TGFβ2 through RNA interference with Furin. We will harvest autologous cancer cells from patients with advanced refractory cancer. We have constructed a bi-shRNAfurin / GMCSF (Vigil™) expression vector plasmid and have successfully demonstrated preclinical activity of the vector function following transfection by electroporation and irradiation of ex vivo autologous tumor cells.
- Conditions
- Ewings Sarcoma, Non Small Cell Lung Cancer, Liver Cancer
- Being tested
- Vigil™
- Keywords
- Ewings Sarcoma, Non Small Cell Lung Cancer, Liver Cancer
- Medical subject headings
- Sarcoma, Ewing, Carcinoma, Non-Small-Cell Lung, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigil™Biological
Also called bi-shRNAfurin and GMCSF Augmented Autologous Tumor, Cell Vaccine, formerly known as FANG™ Vaccine
Patients will be treated once a month as long as sufficient material is available for up to 12 doses
Vigil™Biological
Also called bi-shRNAfurin and GMCSF Augmented Autologous Tumor, Cell Vaccine, formerly known as FANG™ Vaccine
Patients will be treated once a month as long as sufficient material is available for up to 12 doses
Vigil™Biological
Also called bi-shRNAfurin and GMCSF Augmented Autologous Tumor, Cell Vaccine, formerly known as FANG™ Vaccine
Patients will be treated once a month as long as sufficient material is available for up to 12 doses
| Study group | Role | What they receive |
|---|---|---|
| 1 x 10 ^7 cells/injection | Experimental | Vigil™ Receives: Biological: Vigil™ |
| 2.5 x 10 ^7 cells/injection | Experimental | Vigil™ Receives: Biological: Vigil™ |
| 1 x 10^6 or 4 x 10^6 cells/injection | Experimental | Vigil™ Receives: Biological: Vigil™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety following the administration of bi-shRNAfurin and GMCSF autologous tumor cell (Vigil™) vaccine in advanced solid tumor patients who have no acceptable form of standard therapy with curative intent.
Measured: Participants will be followed for life
Secondary outcomes (1)
To determine time to progression. To evaluate the effect of Vigil™ vaccine on immune stimulation. To evaluate whether lower cell doses would activate ELISPOT responses and to compare durability of dose elicited responses.
Measured: Participants will be followed for life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startDec 2009
- Primary completion6 Dec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ewings SarcomaStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gradalis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minal Barve, MD, Principal investigator, Mary Crowley Cancer Research Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061840
- Sponsor's protocol ID
- CL-PTL-101
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2010
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nemunaitis J, Barve M, Orr D, Kuhn J, Magee M, Lamont J, Bedell C, Wallraven G, Pappen BO, Roth A, Horvath S, Nemunaitis D, Kumar P, Maples PB, Senzer N. Summary of bi-shRNA/GM-CSF augmented autologous tumor cell immunotherapy (FANG) in advanced cancer of the liver. Oncology. 2014;87(1):21-9. doi: 10.1159/000360993. Epub 2014 Jun 25.
PubMed 24968881Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
PubMed 22186789Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J. Three-year Follow up of GMCSF/bi-shRNA(furin) DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Aug;24(8):1478-83. doi: 10.1038/mt.2016.86. Epub 2016 Apr 25.
PubMed 27109631Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-1109. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.
PubMed 25917459Oh J, Barve M, Senzer N, Aaron P, Manning L, Wallraven G, Bognar E, Stanbery L, Horvath S, Manley M, Nemunaitis J, Walter A, Rocconi RP. Long-term follow-up of Phase 2A trial results involving advanced ovarian cancer patients treated with Vigil(R) in frontline maintenance. Gynecol Oncol Rep. 2020 Sep 17;34:100648. doi: 10.1016/j.gore.2020.100648. eCollection 2020 Nov. No abstract available.
PubMed 33364285Rocconi RP, Stanbery L, Madeira da Silva L, Barrington RA, Aaron P, Manning L, Horvath S, Wallraven G, Bognar E, Walter A, Nemunaitis J. Long-Term Follow-Up of Gemogenovatucel-T (Vigil) Survival and Molecular Signals of Immune Response in Recurrent Ovarian Cancer. Vaccines (Basel). 2021 Aug 12;9(8):894. doi: 10.3390/vaccines9080894.
PubMed 34452019
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer
- ClinicalTrials.gov ID
- NCT01061840
- Acronym / sponsor ID
- CL-PTL-101
- Conditions
- Ewings Sarcoma, Non Small Cell Lung Cancer, Liver Cancer
- Keywords
- Ewings Sarcoma, Non Small Cell Lung Cancer, Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gradalis, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 3 Feb 2010 (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.
Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the site of intradermal injection and promoting antigen presentation. The furin bifunctional shRNA blocks furin protein production at the post transcriptional and translational levels. This decrease in furin in turn decreases the conversion of the proforms TGFβ1 and TGFβ2 proteins. Also, reduced furin protein levels have a negative feedback inhibition on TGFβ1 and TGFβ2 gene expression, decreasing the levels of their mRNAs. The resulting decrease in TGFβ1 and TGFβ2 proteins reduces the local immunosuppression they cause and promotes tumor surface antigen and MHC protein display.
Detailed description
Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, we have designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance. We have completed clinical investigations using two different gene vaccine approaches to induce enhancement of tumor antigen recognition which have demonstrated therapeutic efficacy. Specifically, both the use of a GMCSF gene transduced vaccine (GVAX®) and a TGFβ2 antisense gene vaccine (Lucanix®), in separate trials, have demonstrated similar beneficial effects without any evidence of significant toxicity in advanced cancer patients. The GMCSF transgene directly stimulates increased expression of tumor antigen(s) and enhances dendritic cell migration to the vaccination site. TGFβ2 blockade following intracellular TGFβ2 antisense gene expression reduces production of immune inhibiting activity at the vaccine site. This appears to be one of the primary mechanisms of inhibition of immune responsiveness in glioblastoma and lung cancer. In a subsequent Phase I trial we combined both active principles in one autologous vaccine, TAG. TAG vaccine has an excellent safety profile in the first nineteen patients treated (enrollment open to any solid tumor) with one documented CR (melanoma). However, TGFβ1 is the dominant TGFβ family inhibitory effector in the majority of other solid tumors. We describe a unique method of inhibiting both TGFβ1 and TGFβ2 through RNA interference with Furin. We will harvest autologous cancer cells from patients with advanced refractory cancer. We have constructed a bi-shRNAfurin / GMCSF (Vigil™) expression vector plasmid and have successfully demonstrated preclinical activity of the vector function following transfection by electroporation and irradiation of ex vivo autologous tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 x 10 ^7 cells/injection | Experimental | Biological: Vigil™Vigil™ |
| 2.5 x 10 ^7 cells/injection | Experimental | Biological: Vigil™Vigil™ |
| 1 x 10^6 or 4 x 10^6 cells/injection | Experimental | Biological: Vigil™Vigil™ |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion may not be a candidate for curative surgery or radiation therapy). Successful vaccine manufacture has resulted from tissue/fluid obtained from the following major organ systems: digestive, endocrine, reproductive, respiratory, and urinary.Individuals manufactured under CL-PTL 105 (Phase II Ovarian) may be eligible for enrollment without advanced or metastatic disease.
- Patients with well differentiated thyroid cancer are eligible for protocol as follows:
- Note: in Categories a and b, patients can be followed using US locally in addition to standard diagnostic followup menu but, if US only is positive, a FDG-PET or MRI will be obtained. If negative, a rising thyroglobulin titer is required in which case response will be monitored by continued US and suppressed and/or stimulated thyroglobulin. Thyroglobulin titer cannot be used if anti-thyroglobulin antibodies are present).
- Completed all acceptable therapies with curative intent that are the current standard of care for their respective diseases. If no conventional therapy available, patient may participate after review by sponsor.
- Recovered from all clinically relevant toxicities related to prior therapies
Key exclusion criteria (14 listed)
- Surgery involving general anesthesia, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to entering the study. Palliative radiotherapy is allowable. Collection of lumenal tissue for vaccine manufacture must be avoided.
- Patients must not have received any other investigational agents within 30 days prior to vaccination.
- Concurrent tumor-specific hormonal therapy or antiestrogens. (Individuals manufactured under CL-PTL 105 (Phase II Ovarian) are not subject to this exclusion).
- Patients with known active or symptomatic brain metastases prior to vaccination.
- Patients with compromised pulmonary disease.
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 |
|---|---|---|
| Vigil™Also: bi-shRNAfurin and GMCSF Augmented Autologous Tumor, Cell Vaccine, formerly known as FANG™ VaccinePatients will be treated once a month as long as sufficient material is available for up to 12 doses | Biological | 1 x 10 ^7 cells/injection |
| Vigil™Also: bi-shRNAfurin and GMCSF Augmented Autologous Tumor, Cell Vaccine, formerly known as FANG™ VaccinePatients will be treated once a month as long as sufficient material is available for up to 12 doses | Biological | 2.5 x 10 ^7 cells/injection |
| Vigil™Also: bi-shRNAfurin and GMCSF Augmented Autologous Tumor, Cell Vaccine, formerly known as FANG™ VaccinePatients will be treated once a month as long as sufficient material is available for up to 12 doses | Biological | 1 x 10^6 or 4 x 10^6 cells/injection |
Primary outcome
To determine safety following the administration of bi-shRNAfurin and GMCSF autologous tumor cell (Vigil™) vaccine in advanced solid tumor patients who have no acceptable form of standard therapy with curative intent.
Time frame: Participants will be followed for life
1 secondary outcome
To determine time to progression. To evaluate the effect of Vigil™ vaccine on immune stimulation. To evaluate whether lower cell doses would activate ELISPOT responses and to compare durability of dose elicited responses.
Time frame: Participants will be followed for life.
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 15 Mar 2022.
- Background: PubMed 24968881Nemunaitis J, Barve M, Orr D, Kuhn J, Magee M, Lamont J, Bedell C, Wallraven G, Pappen BO, Roth A, Horvath S, Nemunaitis D, Kumar P, Maples PB, Senzer N. Summary of bi-shRNA/GM-CSF augmented autologous tumor cell immunotherapy (FANG) in advanced cancer of the liver. Oncology. 2014;87(1):21-9. doi: 10.1159/000360993. Epub 2014 Jun 25.
- Results publication: PubMed 22186789Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
- Results publication: PubMed 27109631Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J. Three-year Follow up of GMCSF/bi-shRNA(furin) DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Aug;24(8):1478-83. doi: 10.1038/mt.2016.86. Epub 2016 Apr 25.
- Results publication: PubMed 25917459Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-1109. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.
- Results publication: PubMed 33364285Oh J, Barve M, Senzer N, Aaron P, Manning L, Wallraven G, Bognar E, Stanbery L, Horvath S, Manley M, Nemunaitis J, Walter A, Rocconi RP. Long-term follow-up of Phase 2A trial results involving advanced ovarian cancer patients treated with Vigil(R) in frontline maintenance. Gynecol Oncol Rep. 2020 Sep 17;34:100648. doi: 10.1016/j.gore.2020.100648. eCollection 2020 Nov. No abstract available.
- Results publication: PubMed 34452019Rocconi RP, Stanbery L, Madeira da Silva L, Barrington RA, Aaron P, Manning L, Horvath S, Wallraven G, Bognar E, Walter A, Nemunaitis J. Long-Term Follow-Up of Gemogenovatucel-T (Vigil) Survival and Molecular Signals of Immune Response in Recurrent Ovarian Cancer. Vaccines (Basel). 2021 Aug 12;9(8):894. doi: 10.3390/vaccines9080894.
- Individual participant dataSharing planned: No
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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.
Minal Barve, MD principal investigator
Mary Crowley Cancer Research Centers
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vigil™ in people with Ewings Sarcoma and Non Small Cell Lung Cancer, run by Gradalis, Inc. at 4 sites 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 18 inclusion and 14 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
To determine safety following the administration of bi-shRNAfurin and GMCSF autologous tumor cell (Vigil™) vaccine in advanced solid tumor patients who have no acceptable form of standard therapy with curative intent. (time frame: Participants will be followed for life). 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 NCT01061840, which also lists 6 linked publications.
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 15 Mar 2022.