Vaccine Therapy in Treating Patients With Recurrent Glioblastoma

NCT03360708 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: MC1772NCI-2017-02159
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.

Conditions

Giant Cell Glioblastoma; Recurrent Glioblastoma; Recurrent Gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Incidence of significant toxicity will be estimated by the number of patients with significant toxicity divided by the total number of evaluable patients.

  Up to 5 years

Secondary Outcomes (7)

• Clinical benefit rate

  Up to 5 years

• Duration of response

  Date at which the patient?s objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years

• Feasibility

  Up to 5 years

• Overall response rate

  Up to 5 years

• Overall survival

  Time from study registration to progression and death due to any cause, assessed up to 5 years

Other Outcomes (1)

• Change in immunologic correlates

  Baseline up to 5 years

Study Arms (1)

Treatment (vaccine therapy)

EXPERIMENTAL

Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Biological: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vaccine therapy)

Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine BIOLOGICAL

Given ID

Treatment (vaccine therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First or second recurrence of previously histologically confirmed glioblastoma (grade 4 astrocytoma)
• NOTE: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) may be included, primitive neuroectodermal tumor (PNET) variants are excluded; grade 4 oligodendrogliomas or oligoastrocytomas are specifically excluded
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• Absolute neutrophil count (ANC) \>= 1500/uL
• Monocytes \>= 300/uL
• Platelets (PLT) \>= 100,000/uL
• Hemoglobin (HgB) \>= 9.0 g/dL
• Total bilirubin =\< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3 x ULN
• Creatinine =\< 1.5 x ULN
• Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
• Ability to understand and willingness to sign written informed consent
• Willing to return to Mayo Clinic in Rochester, Minnesota for follow-up
• Willing to provide tissue and blood samples for mandatory correlative research purposes
• Fixed or decreasing dose of corticosteroids (or no corticosteroids) \>= 7 days prior to registration

You may not qualify if:

• Prior treatment
• Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
• Surgery =\< 2 weeks prior to registration
• Radiotherapy =\< 12 weeks prior to registration
• Treatment with bevacizumab or any cytotoxic chemotherapy =\< 8 weeks prior to registration
• Any of the following
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B (HepB), or hepatitis C (HepC) positive
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of other malignancy other than glioma
• EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or systemic cancer that has been in documented remission for \> 10 years
• NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ian Parney

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: November 27, 2013
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

US (1)