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Cancer Vaccine

HSPPC-96 for Glioblastoma

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage: First or second recurrence of GBM or gliosarcoma considered to be surgically resectable
No evidence of any systemic autoimmune disease (e.g. Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-surgery
Awards & highlights

Study Summary

This trial is testing whether a vaccine made from a person's own tumor tissue, with or without bevacizumab, is effective in treating recurrent glioblastoma multiforme.

Eligible Conditions
  • Glioblastoma (GBM)
  • Gliosarcoma
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a type of brain cancer called GBM or gliosarcoma that has returned and can be removed through surgery.
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You do not have any autoimmune diseases or weakened immune system. Additionally, you are not taking any medication that suppresses your immune system, except for dexamethasone as mentioned in the study.
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You have not received HSPPC-96 or any other experimental immunotherapy treatment in the past.
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You have not received any treatment specifically targeted at your tumor for your most recent progression.
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You have not received Gliadel® wafers before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-surgery 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 (OS)
Secondary outcome measures
Progression Free Survival (PFS)
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2, HSPPC-96 with bevacizumab at progressionExperimental Treatment2 Interventions
HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days) NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine.
Group II: Arm 1, HSPPC-96 + concomitant bevacizumabExperimental Treatment2 Interventions
HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression.
Group III: Arm 3, BevacizumabActive Control1 Intervention
Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitespen
Not yet FDA approved
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,544 Total Patients Enrolled
7 Trials studying Glioblastoma
744 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,556 Total Patients Enrolled
314 Trials studying Glioblastoma
22,356 Patients Enrolled for Glioblastoma
Agenus Inc.Industry Sponsor
49 Previous Clinical Trials
4,876 Total Patients Enrolled
1 Trials studying Glioblastoma
25 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

How many different medical clinics are participating in this study?

"Patients are currently being recruited for this study at Inova Fairfax Hospital, Jewish Hospital, and Minnesota Oncology Hematology PA-Maplewood. There are also 100 other active recruitment sites."

Answered by AI

Are there any other scientific papers which mention the HSPPC-96 protein?

"At the moment, there are 377 different clinical trials studying HSPPC-96. Out of those, 99 are in Phase 3. Even though most of the research for HSPPC-96 is conducted in Taibei, Taiwan, there are a total of 18929 locations running studies on this potential treatment."

Answered by AI

What are some of the risks associated with taking HSPPC-96?

"Since this is a Phase 2 trial, there is only preliminary evidence to support the safety of HSPPC-96. It received a score of 2."

Answered by AI

Why is HSPPC-96 often recommended to patients?

"HSPPC-96 is most commonly used as a treatment for cancer. It can also be used to treat multiple other conditions such as recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer following initial surgical resection, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Are patients currently being accepted for this trial?

"The clinical trial mentioned is not currently seeking patients, as seen on clinicaltrials.gov. This research was initially posted on May 1st, 2013 and last updated on August 16th, 2021. Even though this study isn't recruiting, there are 1824 other trials that are."

Answered by AI

How many people can join this trial at most?

"This particular clinical trial is not currently enrolling patients. However, 377 other studies posted on the website are actively looking for participants with gliosarcoma. For context, 1447 studies are currently recruiting across all topics."

Answered by AI
~8 spots leftby Mar 2025