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GlioblastomaPhase 2NCT01903330

ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme

A Phase 2 study testing ERC1671, GM-CSF and Cyclophosphamide in people with Glioblastoma and Gliosarcoma, run by Epitopoietic Research Corporation at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with recurrent/progressive, bevacizumab naïve glioblastoma multiforme… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Gliosarcoma
What is being tested?
ERC1671, GM-CSF and Cyclophosphamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
3 sitesUnited States
Study dates
Mar 2014to Jun 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 multiforme and gliosarcoma) and meet the following inclusion criteria:
  • Age ≥18 years of age.
  • Histologic diagnosis of glioblastoma or gliosarcoma (WHO Grade IV).
  • KPS of ≥ 70%.
  • Life expectancy > 12 weeks.
  • First or second relapse of glioblastoma.
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  • Previous treatment for glioblastoma must include surgery (biopsy, partial resection, or full surgical resection), conventional radiation therapy and temozolomide (TMZ).
  • MRI record must be obtained showing the MRI was conducted 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 per iRANO 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 1 severity, except for alopecia and hematologic toxicity. Patients taking temozolomide can start study treatment 23 days from the last temozolamide 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.
  • Pre-surgical 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 > 450/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.
  • 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;
  • Prior receipt of bevacizumab, or bevacizumab biosimilars or other VEGF- or VEGF receptor-targeted agents
  • Known contraindication or hypersensitivity to any component of bevacizumab.
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  • 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 intra-abdominal 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 6 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 must use a reliable form of contraception during study participation.
  • 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

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide)+Bevacizumab vs. (Placebo Injection/Placebo Pill) +Bevacizumab in the Treatment of Recurrent/Progressive, Bevacizumab naïve Glioblastoma Multiforme and Glioasarcoma Patients (WHO Grade IV Malignant Gliomas, GBM)

This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with recurrent/progressive, bevacizumab naïve glioblastoma multiforme and gliosarcoma (World Health Organization (WHO) grade IV malignant gliomas, GBM).

Read the detailed description

This is a blinded Phase II study of ERC1671 in combination with bevacizumab in patients with relapsed, bevacizumab naive glioblastoma. The patients who will be randomized (in a 1:1 ratio) to receive either ERC 1671 in combination with GM-CSF and cyclophosphamide or a placebo control, in combination with bevacizumab. The study will be double blinded.

ERC1671/GM-CSF will be intradermally administered, while cyclophosphamide is orally administered. GM-CSF dose is 500mcg fixed dose and cyclophosphamide dose is 50 mg/day. Bevacizumab or approved bevacizumab biosimilars are administered as standard of care at 10 mg/kg every 2 weeks.

The treatment cycles will be 28 days long.

Being tested
ERC1671, GM-CSF, Cyclophosphamide, Oral Control (Sucrose pill), Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%))
Keywords
ERC1671, GM-CSF, Cyclophosphamide, Bevacizumab
Medical subject headings
Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERC1671Drug

    Also called Gliovac

    Given intradermally

  • GM-CSFDrug

    Also called Leukine®, sargramostim

    Given intradermally

  • CyclophosphamideDrug

    Also called 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

    Given PO. Drug class: Alkylating Agent; Antineoplastic Agent; Nitrogen Mustard.

  • Oral Control (Sucrose pill)Drug

    Given PO

  • Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%))Drug

    Given IV

  • Bevacizumab/Bevacizumab BiosimilarDrug

    Also called Avastin, MVASI, bevacizumab-awwb, bevacizumab-bvzr

    Given IV. Drug class: Immunological Agent; Monoclonal Antibody.

Study groups in NCT01903330
Study groupRoleWhat they receive
(ERC1671/GM-CSF/Cyclophosphamide)+bevacizumab/bevacizumab biosimilarExperimentalERC1671 and GM-CSF will be intradermally administered, while cyclophosphamide is orally administered. GM-CSF dose is 500mcg fixed dose and cyclophosphamide dose is 50 mg/day. Bevacizumab or approved bevacizumab biosimilars are administered as standard of care at 10 mg/kg every 2 weeks. The treatment will be repeated every 28 days until progression of disease or intolerance.
Receives: Drug: ERC1671; Drug: GM-CSF; Drug: Cyclophosphamide; Drug: Bevacizumab/Bevacizumab Biosimilar
(Placebo Injection/Placebo Pill) +Bevacizumab/bevacizumab biosimilarPlacebo comparatorThe control group will have the same study schedule except that the patients will be receiving the Oral Control on the Cyclophosphamide treatment days and the Injectable control on the GM-CSF + ERC1671 treatment days. The control group will receive bevacizumab or approved bevacizumab biosimilar just as the active treatment group above. The treatment will be repeated every 28 days until progression of disease or intolerance.
Receives: Drug: Oral Control (Sucrose pill); Drug: Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%)); Drug: Bevacizumab/Bevacizumab Biosimilar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival at 12 months of patients with recurrent, bevacizumab naïve glioblastoma treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls.

    To evaluate overall survival in patients with with recurrent, bevacizumab naïve glioblastoma treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls.

    Measured: 12 months

Secondary outcomes (4)

  1. Rate of Progression-Free Survival

    Progression-free survival will be defined as the time from Day 1 to the date of progression or death due to any cause.

    Measured: 12 months

  2. Immune Response

    The patient's immune response evaluation will include cytotoxic T lymphocytes (CTL) (CD3+/cluster of differentiation (CD)8+) and Treg (CD3+/CD4+/cluster of differentiation 25+ (CD25+)/CD127low) populations where CD refers to cluster of differentiation. Cytokine analyses should initially be limited to IFN-ɣ, TNF and IL-6. Further immune studies should include transforming growth factor (TGF)-B2, IL-12, IL-10.

    Measured: 12 months

  3. Percentage of Grade 3-5 Adverse Events

    Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Safety will also be assessed by clinical laboratory tests, physical examinations, vital sign measurements and the incidence and severity of adverse events (AEs).

    Measured: 12 months

  4. Rate of Radiographic Response as assessed using MacDonald Criteria or IRANO

    Patients will be followed both clinically and radiographically every 6 weeks for evidence of tumor progression. Tumor response will be assessed using the MacDonald Criteria or iRANO, Immunotherapy Response Assessment in Neuro-Oncology.

    iRANO/MacDonald CRITERIA:

    • Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan.
    • Partial response (PR): Greater than or equal to a 50% reduction in the size (sum of products of the largest diameter, SPD) for all enhancing lesions.
    • Stable Disease (SD): SPD <50% decrease to <25% increase, does not qualify for CR, PR, or progression.
    • Progressive Disease (PD): Greater than or equal to a 25% increase in SPD.
    • Unable to Assess (UA): Some target lesions cannot be evaluated because of technical factors.

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903330
Sponsor's protocol ID
UCI13-14 ERC1671-H02 2013-9863
Other IDs
UCI 13-14, 2013-9863
Status last verified
May 2022
First submitted
26 Jun 2013
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Schijns VE, Pretto C, Devillers L, Pierre D, Hofman FM, Chen TC, Mespouille P, Hantos P, Glorieux P, Bota DA, Stathopoulos A. First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined allo- and auto-immune tumor reactivity. Vaccine. 2015 May 28;33(23):2690-6. doi: 10.1016/j.vaccine.2015.03.095. Epub 2015 Apr 10.

    PubMed 25865468

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ERC1671, GM-CSF and Cyclophosphamide in people with Glioblastoma and Gliosarcoma, run by Epitopoietic Research Corporation at 3 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 22 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. Some participants in this study may receive a placebo. 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?

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?

Overall Survival at 12 months of patients with recurrent, bevacizumab naïve glioblastoma treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls. (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 NCT01903330, 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 5 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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