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Chemotherapy

ERC1671 for Gliosarcoma

Phase 2
Waitlist Available
Led By Daniela A. Bota, MD, PhD
Research Sponsored by Epitopoietic Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic diagnosis of glioblastoma or gliosarcoma (WHO Grade IV).
KPS of ≥ 70%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

Study Summary

This trial looks at a new treatment for glioblastoma and gliosarcoma (both brain cancer) that includes the drug ERC1671. It is compared to the standard treatment, which is just bevacizumab (a different drug).

Eligible Conditions
  • Gliosarcoma
  • Glioblastoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Immune Response
Percentage of Grade 3-5 Adverse Events
Rate of Progression-Free Survival
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: (ERC1671/GM-CSF/Cyclophosphamide)+bevacizumab/bevacizumab biosimilarExperimental Treatment4 Interventions
ERC1671 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.
Group II: (Placebo Injection/Placebo Pill) +Bevacizumab/bevacizumab biosimilarPlacebo Group3 Interventions
The 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Epitopoietic Research CorporationLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
University of California, IrvineOTHER
536 Previous Clinical Trials
1,921,516 Total Patients Enrolled
Daniela A. Bota, MD, PhDPrincipal InvestigatorUniversity of California, Irvine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we looking for more participants in this clinical trial at the moment?

"This particular trial is not looking for new participants at the moment. It was originally posted on March 1st, 2014 but has since been updated on May 10th, 2022. There are currently 459 other trials recruiting patients with gliosarcoma and 1357 different trials seeking ERC1671 participants."

Answered by AI

How many individuals are being administered lenalidomide in this test group?

"Although this study is not currently looking for patients, it may in the future. According to the latest update on clinicaltrials.gov, the trial was most recently edited on May 10th, 2022. 459 other trials for gliosarcoma and 1357 trials for ERC1671 are actively recruiting participants right now."

Answered by AI

What is ERC1671's current standing with the FDA?

"There is limited data on ERC1671's safety, but none yet on its efficacy. Our team has given it a score of 2."

Answered by AI

Is this the first time ERC1671 has been used in a clinical setting?

"ERC1671 was first trialled in 1997 at City of Hope Comprehensive Cancer Center. So far, 2688 rounds of clinical trials have completed. Currently, there are 1357 ongoing clinical trials with a large portion happening in Boston, Massachusetts."

Answered by AI

What are the primary conditions that ERC1671 has been known to treat?

"ERC1671 is frequently used to treat lymphoma, but can also be effective in treating acute lymphoblastic leukemia (all), hypochloremic state, and electrolyte replacement therapy."

Answered by AI
~8 spots leftby Mar 2025