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Vaccine Therapy With Bevacizu...

Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Last Updated: 2025-01-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-19

Study Completion Date

2023-05-22

Brief Summary

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This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.

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Detailed Description

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The purpose of this study is to compare the effects of a vaccine with bevacizumab versus bevacizumab alone on a patient's brain tumor. The vaccine is called heat shock protein peptide complex 96 (HSPPC-96). HSPPC-96 is experimental. Specifically, HSPPC-96 is a protein that may work to help the body have a response against remaining brain tumor cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, patients will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if the tumor comes back, or bevacizumab alone. The use of HSPPC-96 and bevacizumab is investigational.

The primary objective of the study is to determine whether there is an overall survival advantage of HSPPC-96 administered with bevacizumab, given concomitantly or at the point of progression, in comparison with bevacizumab alone in patients with surgically resectable recurrent glioblastoma multiforme.

The secondary objectives are:

1. to evaluate the safety and tolerability of HSPPC-96 with bevacizumab
2. to evaluate the progression free survival of HSPPC-96 with bevacizumab, given concomitantly or at the point of progression.

Patients must undergo surgery within 28 days from pre-registration. There must be confirmation of adequacy of tissue for vaccine manufacture, tumor tissue submitted to Agenus, confirmation of ≥ 90% resection by central radiology review and vaccine manufacture of at least six vials. Patients will be randomized to one of three treatment arms. Please see the "Arms" section for more details.

Patients will be monitored approximately 5 years post-surgery.

Conditions

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Recurrent Glioblastoma Recurrent Adult Brain Tumor Gliosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1, HSPPC-96 + concomitant bevacizumab

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 Type EXPERIMENTAL

HSPPC-96

Intervention Type BIOLOGICAL

intradermal infusion

bevacizumab

Intervention Type DRUG

intravenous

Arm 2, HSPPC-96 with bevacizumab at progression

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 Type EXPERIMENTAL

HSPPC-96

Intervention Type BIOLOGICAL

intradermal infusion

bevacizumab

Intervention Type DRUG

intravenous

Arm 3, Bevacizumab

Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days)

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

intravenous

Interventions

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HSPPC-96

intradermal infusion

Intervention Type BIOLOGICAL

bevacizumab

intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation
* No current New York Heart Association classification II, III or IV congestive heart failure
* No significant bleeding within the past 6 months; no bleeding diathesis or coagulopathy
* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months
* 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
* Age ≥ 18 years of age
* Karnofsky functional status rating ≥70
* No more than 16 mg dexamethasone (or equivalent) per day
* Non-pregnant and non-nursing

Registration (Post-Surgery) Eligibility Criteria

* Pre-registration eligibility criteria continue to be met
* Histologic documentation: confirmed histological diagnosis of recurrent GBM or gliosarcoma
* ≥ 90% surgical resection of recurrent GBM confirmed by central radiology review by MRI with or without gadolinium per institutional guidelines. A CT scan is allowable in place of MRI only in situations where an MRI is contraindicated (e.g., patient has a heart pacemaker, metallic devices in the eye, brain or spine, severe claustrophobia).
* ≥ 7 grams of resected tumor available for vaccine manufacture as determined by institutional pathologist
* Availability of ≥ 6 clinical vials of HSPPC-96
* Required Initial Laboratory Values:

* Granulocytes ≥1,500/µL
* Platelet count ≥100,000/µL
* Total Bilirubin ≤ 2.0 x ULN
* UPC ratio \<1 or Urine protein ≤ 1+
* Calculated creatinine clearance ≥ 45 ml/min
* SGOT/SGPT(AST/ALT) ≤ 2.5 x ULN
* No serious, non-healing wounds or ulcers
* At least 7 days since any minor surgery such as port placement
* No major surgical procedures, open biopsy or significant traumatic injury ≤ 28 days prior to registration or anticipation of need for elective or planned major surgical procedure during the study. Core biopsy or other minor surgical procedures ≤7 days prior to registration.
* No active or recent hemoptysis (≥½ teaspoon of bright red blood per episode) ≤ 30 days prior to registration
* No new bleeding on D28 (+/-3) MRI (or CT if MRI is contraindicated)
* No clinical deterioration at the time of registration/randomization
* If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Parney, MD, PhD

Role: STUDY_CHAIR

Mayo Clinic

Orin Bloch, MD

Role: STUDY_CHAIR

Northwestern University

Locations

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