Glioma, MalignantPhase 2NCT05366062
ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab
A Phase 2 study testing ERC1671, GM-CSF and Cyclophosphamide in people with Glioma, Malignant, run by Epitopoietic Research Corporation at 1 site in Thailand.
Trial summary
This is a treatment clinical trial to assess the efficacy of ERC1671 in combination with bevacizumab and pembrolizumab in patients with GBM that has progressed following treatment with radiation and temozolomide. Patients will have surgery to collect the maximum amount of GBM tissue that can be reasonably collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- ERC1671, GM-CSF and Cyclophosphamide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2022to 31 Jul 2026
- Phase
- Phase 2
- 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
- Patients must have histologically confirmed diagnosis of a recurrent/progressive WHO grade IV malignant gliomas (glioblastoma) and meet the following inclusion criteria:
- Age ≥18 years of age.
- KPS of ≥ 60%.
- Life expectancy > 12 weeks.
- First, second, third or fourth relapse of glioblastoma.
- Previous treatment for glioblastoma must include surgery (biopsy, partial resection, or full surgical resection), conventional radiation therapy and temozolomide (TMZ).
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- MRI record must be obtained showing the MRI was done at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy, or at least 4 weeks after radiation for a new lesion outside the prior primary radiation field unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart.
- If prior therapy with gamma knife or other focal high-dose radiation, must have subsequent histologic documentation of local relapse, or relapse with new lesion outside the irradiated field.
- Resolution of all chemotherapy or radiation-related toxicities ≤ CTCAE Grade severity, except for alopecia and hematologic toxicity. Patients taking temozolomide can start study treatment 23 days from the last temozolomide dose. For all other chemotherapy drugs, study treatment can start as long as all adverse events related to their prior treatment are no higher than Grade 1.
- Systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1.
- Bi-dimensionally measurable disease (as per iRANO criteria).
- Patients must have normal organ and marrow function as defined below:
- Hemoglobin (Hbg) > 9g/dL,
- Leukocytes >1,500/mcL
- Absolute neutrophil count>1,000/mcL
- CD4 count > 300/mcl
- Platelets >125,000/mcL
- Serum bilirubin = 1.5 × upper limit of normal (ULN) or = 3 x ULN if Gilbert's disease is documented AST(SGOT) and ALT(SGPT)<2.5 x institutional upper limit of normal
- Serum creatinine < 1.5 mg/dl
- Signed informed consent approved by the Institutional Review Board;
- If sexually active, patients must agree to take contraceptive measures for the duration of the treatments.
Who cannot join
- Subjects unable to undergo an MRI with contrast
- Subjects able and willing to participate in an open and accruing ERC clinical trial
- Presence of diffuse leptomeningeal disease
- History, presence, or suspicion of metastatic disease
- Administration of immunosuppressive drugs less than 2 weeks prior to first dose of ERC1671 except dexamethasone for cerebral edema as detailed above;
- Known contraindication or hypersensitivity to any component of bevacizumab.
Show all 19Show fewer
- Evidence of recent hemorrhage on screening MRI of the brain with the following exceptions: presence of hemosiderin; resolving hemorrhagic changes related to surgery; presence of punctate hemorrhage in the tumor.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1.
- Evidence of bleeding diathesis or coagulopathy as documented by an elevated PT, PTT or bleeding time and clinically significant;
- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to Day 1.
- Urine protein: creatinine ratio 1.0 at screening;
- Anticipation of need for major surgical procedure during the course of the study.
- Serious non-healing wound, ulcer, or bone fracture.
- Active infection requiring treatment, known immunosuppressive disease, active systemic autoimmune diseases such as lupus, receipt of systemic immunosuppressive therapy, human immunodeficiency virus (HIV) infection, Hepatitis B or Hepatitis C.
- Uncontrolled hypertension, blood pressure of > 150 mmHg systolic and > 100 mmHg diastolic, or history of hypertensive encephalopathy. Subjects with any known uncontrolled inter-current illness including ongoing or active infection, symptomatic congestive heart failure (NYHA Gr.2 or >), myocardial infarction, unstable angina pectoris within the past 12 months
- Stroke, transient ischemic attack, unstable angina, myocardial infarction or congestive heart failure (New York Heart Association Grade II or greater) within the past 12 months. Unstable or severe intercurrent medical conditions, chronic renal disease, or uncontrolled diabetes mellitus.
- Women who are pregnant or lactating. All female patients with reproductive potential must have a negative pregnancy test prior to Day 1 and agree to use reliable contraception whilst study participant.
- Men refusing to exercise a reliable form of contraception.
- History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with Prostate Surface Antigen (PSA) level <ULN.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Bumrungrad International Hospital
Bangkok, Vadhana, 10110
Tanawat Jirakulaporn, MD, +66(0)81803 8611, TanawatJ@bumrungraddoctor.com
Tanawat Jirakulaporn, MD
About this study
Official title: Phase II Clinical Trial to Assess the Efficacy of ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab in Patients Who Have Failed Prior Treatment With Radiation and Temozolomide
This is a treatment clinical trial to assess the efficacy of ERC1671 in combination with bevacizumab and pembrolizumab in patients with GBM that has progressed following treatment with radiation and temozolomide.
Patients will have surgery to collect the maximum amount of GBM tissue that can be reasonably collected. This tissue will be used to manufacturer ERC1671 for the patient.
The patients will receive ERC1671 in combination with GM-CSF and cyclophosphamide, in combination with bevacizumab and pembrolizumab.
Read the detailed description
The treatment cycles will be 28 days long and follow the schedule below. There are 28 days (± 7 days) from surgery date to start of Cycle 1 day 1 to permit production of ERC-D vaccine:
The treatment will be repeated every 28-days until progression of disease, intolerance, or a decision by the physician and/or patient to withdraw from the treatment plan.
Efficacy will be evaluated as a foundation of Overall Survival reported at twelve months (OS12)
Safety will be evaluated, as a secondary objective, throughout the trial by the incidence of serious adverse events (AEs), physical examination findings, vital signs and clinical laboratory test results. SAEs will be graded for severity using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Patients will undergo brain MRI as part of standard care before starting cycle 1 and every 8 weeks thereafter (+/- 7 days) until disease progression, and whenever progression is suspected based on clinical symptoms. Tumor response will be assessed using both the Macdonald and the iRANO response criteria for high-grade gliomas, which considers radiologic imaging, neurological status, and steroid dosing.
Whenever clinically appropriate, stereotactic biopsy or resection will be performed in accordance with standard of care for patients with progressive disease. To differentiate true progression from potentially toxic or therapeutic inflammatory responses presenting as radiographic or clinical changes, histologic verification of progression will be performed whenever feasible and appropriate.
- Conditions
- Glioma, Malignant
- Being tested
- ERC1671, GM-CSF, Cyclophosphamide, Pembrolizumab
- Keywords
- ERC1671, GM-CSF, Cyclophosphamide, Bevacizumab, Pembrolizumab
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERC1671Drug
ERC1671 is an autologous and allogeneic cells and lysates suspension generated from human glioblastoma (GBM) tumors harvested from patients undergoing surgery for glioblastoma. For each patient the treatment is composed of three allogeneic cells vaccine and lysates vaccine (ERC1671 A, B, C) plus from one autologous cells and lysate (ERC1671D).
GM-CSFDrug
Sargramostim (Leukomax®, Leukine®); yeast-derived, recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF)
CyclophosphamideDrug
Cyclophosphamide is an alkylating agent, used for immunopotentiation. This drug is FDA approved and is being used off-label for the condition of hematopoietic stem cell transplant conditioning as an antineoplastic and immunosuppressant agent to modulate immunity.
PembrolizumabDrug
Also called Keytruda
A therapeutic antibody that binds to and blocks PD-1 located on lymphocytes. The receptor is generally responsible for preventing the immune system from attacking the body's own tissues - it is an immune checkpoint inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This is a Treatment Protocol for patients with severe and immediately life-threatening GBM that had surgical resection and first line treatment with radiation therapy and temozolamide per current standard of care. Patients will be treated with recurring 28-day cycles of ERC1671, GM-CSF, Cyclophosphomide, Bevacizumab, and Pembrolizumab until progression of disease and at the discretion of the treating physician. Receives: Drug: ERC1671; Drug: GM-CSF; Drug: Cyclophosphamide; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 12 months
Overall Survival at 12 months as assessed per iRANO Criteria.
Measured: 12 months
Secondary outcomes (3)
Progression-free survival
Dates from date of first injection of vaccine.
Measured: 12 Months
Radiographic Response
Radiographic Response, categorized per iRANO Criteria.
Measured: 12 Months
Number of participants with Adverse Events [Safety and Tolerability]
As indicated by the number and rate of adverse events, categorized by the CTCAE v. 5.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Glioma, MalignantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epitopoietic Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366062
- Sponsor's protocol ID
- ERC1671PEM
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barker FG 2nd, Chang SM, Gutin PH, Malec MK, McDermott MW, Prados MD, Wilson CB. Survival and functional status after resection of recurrent glioblastoma multiforme. Neurosurgery. 1998 Apr;42(4):709-20; discussion 720-3. doi: 10.1097/00006123-199804000-00013.
PubMed 9574634Ben-Efraim S. Immunomodulating anticancer alkylating drugs: targets and mechanisms of activity. Curr Drug Targets. 2001 Jun;2(2):197-212. doi: 10.2174/1389450013348597.
PubMed 11469719BLOOM WH, CARSTAIRS KC, CROMPTON MR, McKISSOCK W. Autologous glioma transplantation. Lancet. 1960 Jul 9;2(7141):77-8. doi: 10.1016/s0140-6736(60)91219-8. No abstract available.
PubMed 13801625Bowles AP Jr, Perkins E. Long-term remission of malignant brain tumors after intracranial infection: a report of four cases. Neurosurgery. 1999 Mar;44(3):636-42; discussion 642-3. doi: 10.1097/00006123-199903000-00110.
PubMed 10069601Brem S, Cotran R, Folkman J. Tumor angiogenesis: a quantitative method for histologic grading. J Natl Cancer Inst. 1972 Feb;48(2):347-56. No abstract available.
PubMed 4347034Bystryn JC, Rigel D, Friedman RJ, Kopf A. Prognostic significance of hypopigmentation in malignant melanoma. Arch Dermatol. 1987 Aug;123(8):1053-5.
PubMed 3631983Clarke JL, Ennis MM, Yung WK, Chang SM, Wen PY, Cloughesy TF, Deangelis LM, Robins HI, Lieberman FS, Fine HA, Abrey L, Gilbert MR, Mehta M, Kuhn JG, Aldape KD, Lamborn KR, Prados MD; North American Brain Tumor Consortium. Is surgery at progression a prognostic marker for improved 6-month progression-free survival or overall survival for patients with recurrent glioblastoma? Neuro Oncol. 2011 Oct;13(10):1118-24. doi: 10.1093/neuonc/nor110. Epub 2011 Aug 2.
PubMed 21813511Coley WB. The treatment of malignant tumors by repeated inoculations of erysipelas. With a report of ten original cases. 1893. Clin Orthop Relat Res. 1991 Jan;(262):3-11. No abstract available.
PubMed 1984929Crane CH, Ellis LM, Abbruzzese JL, Amos C, Xiong HQ, Ho L, Evans DB, Tamm EP, Ng C, Pisters PW, Charnsangavej C, Delclos ME, O'Reilly M, Lee JE, Wolff RA. Phase I trial evaluating the safety of bevacizumab with concurrent radiotherapy and capecitabine in locally advanced pancreatic cancer. J Clin Oncol. 2006 Mar 1;24(7):1145-51. doi: 10.1200/JCO.2005.03.6780.
PubMed 16505434D'Adamo DR, Anderson SE, Albritton K, Yamada J, Riedel E, Scheu K, Schwartz GK, Chen H, Maki RG. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol. 2005 Oct 1;23(28):7135-42. doi: 10.1200/JCO.2005.16.139.
PubMed 16192597Dang Y, Wagner WM, Gad E, Rastetter L, Berger CM, Holt GE, Disis ML. Dendritic cell-activating vaccine adjuvants differ in the ability to elicit antitumor immunity due to an adjuvant-specific induction of immunosuppressive cells. Clin Cancer Res. 2012 Jun 1;18(11):3122-31. doi: 10.1158/1078-0432.CCR-12-0113. Epub 2012 Apr 17.
PubMed 22510348Deorah S, Lynch CF, Sibenaller ZA, Ryken TC. Trends in brain cancer incidence and survival in the United States: Surveillance, Epidemiology, and End Results Program, 1973 to 2001. Neurosurg Focus. 2006 Apr 15;20(4):E1. doi: 10.3171/foc.2006.20.4.E1.
PubMed 16709014Emens LA. GM-CSF-secreting vaccines for solid tumors. Curr Opin Investig Drugs. 2009 Dec;10(12):1315-24.
PubMed 19943203Ammirati M, Galicich JH, Arbit E, Liao Y. Reoperation in the treatment of recurrent intracranial malignant gliomas. Neurosurgery. 1987 Nov;21(5):607-14. doi: 10.1227/00006123-198711000-00001.
PubMed 2827051
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Assess the Efficacy of ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab in Patients Who Have Failed Prior Treatment With Radiation and Temozolomide
- ClinicalTrials.gov ID
- NCT05366062
- Acronym / sponsor ID
- ERC1671PEM
- Conditions
- Glioma, Malignant
- Keywords
- ERC1671, GM-CSF, Cyclophosphamide, Bevacizumab, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Epitopoietic Research CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 9 May 2022 (actual)
- 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.
This is a treatment clinical trial to assess the efficacy of ERC1671 in combination with bevacizumab and pembrolizumab in patients with GBM that has progressed following treatment with radiation and temozolomide.
Patients will have surgery to collect the maximum amount of GBM tissue that can be reasonably collected. This tissue will be used to manufacturer ERC1671 for the patient.
The patients will receive ERC1671 in combination with GM-CSF and cyclophosphamide, in combination with bevacizumab and pembrolizumab.
Detailed description
The treatment cycles will be 28 days long and follow the schedule below. There are 28 days (± 7 days) from surgery date to start of Cycle 1 day 1 to permit production of ERC-D vaccine:
The treatment will be repeated every 28-days until progression of disease, intolerance, or a decision by the physician and/or patient to withdraw from the treatment plan.
Efficacy will be evaluated as a foundation of Overall Survival reported at twelve months (OS12)
Safety will be evaluated, as a secondary objective, throughout the trial by the incidence of serious adverse events (AEs), physical examination findings, vital signs and clinical laboratory test results. SAEs will be graded for severity using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Patients will undergo brain MRI as part of standard care before starting cycle 1 and every 8 weeks thereafter (+/- 7 days) until disease progression, and whenever progression is suspected based on clinical symptoms. Tumor response will be assessed using both the Macdonald and the iRANO response criteria for high-grade gliomas, which considers radiologic imaging, neurological status, and steroid dosing.
Whenever clinically appropriate, stereotactic biopsy or resection will be performed in accordance with standard of care for patients with progressive disease. To differentiate true progression from potentially toxic or therapeutic inflammatory responses presenting as radiographic or clinical changes, histologic verification of progression will be performed whenever feasible and appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: ERC1671, Drug: GM-CSF, Drug: Cyclophosphamide, Drug: PembrolizumabThis is a Treatment Protocol for patients with severe and immediately life-threatening GBM that had surgical resection and first line treatment with radiation therapy and temozolamide per current standard of care. Patients will be treated with recurring 28-day cycles of ERC1671, GM-CSF, Cyclophosphomide, Bevacizumab, and Pembrolizumab until progression of disease and at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically confirmed diagnosis of a recurrent/progressive WHO grade IV malignant gliomas (glioblastoma) and meet the following inclusion criteria:
- Age ≥18 years of age.
- KPS of ≥ 60%.
- Life expectancy > 12 weeks.
- First, second, third or fourth relapse of glioblastoma.
Key exclusion criteria (19 listed)
- Subjects unable to undergo an MRI with contrast
- Subjects able and willing to participate in an open and accruing ERC clinical trial
- Presence of diffuse leptomeningeal disease
- History, presence, or suspicion of metastatic disease
- Administration of immunosuppressive drugs less than 2 weeks prior to first dose of ERC1671 except dexamethasone for cerebral edema as detailed above;
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 |
|---|---|---|
| ERC1671ERC1671 is an autologous and allogeneic cells and lysates suspension generated from human glioblastoma (GBM) tumors harvested from patients undergoing surgery for glioblastoma. For each patient the treatment is composed of three allogeneic cells vaccine and lysates vaccine (ERC1671 A, B, C) plus from one autologous cells and lysate (ERC1671D). | Drug | Treatment Arm |
| GM-CSFSargramostim (Leukomax®, Leukine®); yeast-derived, recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) | Drug | Treatment Arm |
| CyclophosphamideCyclophosphamide is an alkylating agent, used for immunopotentiation. This drug is FDA approved and is being used off-label for the condition of hematopoietic stem cell transplant conditioning as an antineoplastic and immunosuppressant agent to modulate immunity. | Drug | Treatment Arm |
| PembrolizumabAlso: KeytrudaA therapeutic antibody that binds to and blocks PD-1 located on lymphocytes. The receptor is generally responsible for preventing the immune system from attacking the body's own tissues - it is an immune checkpoint inhibitor. | Drug | Treatment Arm |
Primary outcome
Overall Survival at 12 months
Time frame: 12 months
Overall Survival at 12 months as assessed per iRANO Criteria.
3 secondary outcomes
Progression-free survival
Time frame: 12 Months
Radiographic Response
Time frame: 12 Months
Number of participants with Adverse Events [Safety and Tolerability]
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Background: PubMed 9574634Barker FG 2nd, Chang SM, Gutin PH, Malec MK, McDermott MW, Prados MD, Wilson CB. Survival and functional status after resection of recurrent glioblastoma multiforme. Neurosurgery. 1998 Apr;42(4):709-20; discussion 720-3. doi: 10.1097/00006123-199804000-00013.
- Background: PubMed 11469719Ben-Efraim S. Immunomodulating anticancer alkylating drugs: targets and mechanisms of activity. Curr Drug Targets. 2001 Jun;2(2):197-212. doi: 10.2174/1389450013348597.
- Background: PubMed 13801625BLOOM WH, CARSTAIRS KC, CROMPTON MR, McKISSOCK W. Autologous glioma transplantation. Lancet. 1960 Jul 9;2(7141):77-8. doi: 10.1016/s0140-6736(60)91219-8. No abstract available.
- Background: PubMed 10069601Bowles AP Jr, Perkins E. Long-term remission of malignant brain tumors after intracranial infection: a report of four cases. Neurosurgery. 1999 Mar;44(3):636-42; discussion 642-3. doi: 10.1097/00006123-199903000-00110.
- Background: PubMed 4347034Brem S, Cotran R, Folkman J. Tumor angiogenesis: a quantitative method for histologic grading. J Natl Cancer Inst. 1972 Feb;48(2):347-56. No abstract available.
- Background: PubMed 3631983Bystryn JC, Rigel D, Friedman RJ, Kopf A. Prognostic significance of hypopigmentation in malignant melanoma. Arch Dermatol. 1987 Aug;123(8):1053-5.
- Background: PubMed 21813511Clarke JL, Ennis MM, Yung WK, Chang SM, Wen PY, Cloughesy TF, Deangelis LM, Robins HI, Lieberman FS, Fine HA, Abrey L, Gilbert MR, Mehta M, Kuhn JG, Aldape KD, Lamborn KR, Prados MD; North American Brain Tumor Consortium. Is surgery at progression a prognostic marker for improved 6-month progression-free survival or overall survival for patients with recurrent glioblastoma? Neuro Oncol. 2011 Oct;13(10):1118-24. doi: 10.1093/neuonc/nor110. Epub 2011 Aug 2.
- Background: PubMed 1984929Coley WB. The treatment of malignant tumors by repeated inoculations of erysipelas. With a report of ten original cases. 1893. Clin Orthop Relat Res. 1991 Jan;(262):3-11. No abstract available.
- Background: PubMed 16505434Crane CH, Ellis LM, Abbruzzese JL, Amos C, Xiong HQ, Ho L, Evans DB, Tamm EP, Ng C, Pisters PW, Charnsangavej C, Delclos ME, O'Reilly M, Lee JE, Wolff RA. Phase I trial evaluating the safety of bevacizumab with concurrent radiotherapy and capecitabine in locally advanced pancreatic cancer. J Clin Oncol. 2006 Mar 1;24(7):1145-51. doi: 10.1200/JCO.2005.03.6780.
- Background: PubMed 16192597D'Adamo DR, Anderson SE, Albritton K, Yamada J, Riedel E, Scheu K, Schwartz GK, Chen H, Maki RG. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol. 2005 Oct 1;23(28):7135-42. doi: 10.1200/JCO.2005.16.139.
- Background: PubMed 22510348Dang Y, Wagner WM, Gad E, Rastetter L, Berger CM, Holt GE, Disis ML. Dendritic cell-activating vaccine adjuvants differ in the ability to elicit antitumor immunity due to an adjuvant-specific induction of immunosuppressive cells. Clin Cancer Res. 2012 Jun 1;18(11):3122-31. doi: 10.1158/1078-0432.CCR-12-0113. Epub 2012 Apr 17.
- Background: PubMed 16709014Deorah S, Lynch CF, Sibenaller ZA, Ryken TC. Trends in brain cancer incidence and survival in the United States: Surveillance, Epidemiology, and End Results Program, 1973 to 2001. Neurosurg Focus. 2006 Apr 15;20(4):E1. doi: 10.3171/foc.2006.20.4.E1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ERC1671, GM-CSF and Cyclophosphamide in people with Glioma, Malignant, run by Epitopoietic Research Corporation at 1 site in Thailand.
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 21 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 13 May 2022. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Elliott, PhD (+1-416-721-5116, jelliot@erc-usa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival at 12 months (time frame: 12 months). 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 NCT05366062, which also lists 14 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 13 May 2022.