Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT01957956 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: MC1272NCI-2013-01743
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy and temozolomide may be an effective treatment for glioblastoma.

Conditions

Giant Cell Glioblastoma; Glioblastoma; Gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of significant toxicity, defined as grade 3 or higher adverse event that is possibly, probably, or definitely related to treatment measured using 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 84 days

Secondary Outcomes (5)

• Change in immunologic correlates

  Baseline to up to 5 years

• Clinical benefit rate

  Up to 5 years

• Duration of response

  Up to 5 years

• Overall response rate

  Up to 5 years

• Time to response

  Up to 5 years

Study Arms (1)

Treatment (vaccine therapy and temozolomide)

EXPERIMENTAL

COURSE 1: Patients receive temozolomide PO daily on days 1-5. COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5. COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1. COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vaccine therapy and temozolomide)

Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine BIOLOGICAL

Given ID

Treatment (vaccine therapy and temozolomide)

Temozolomide DRUG

Given PO

Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac

Treatment (vaccine therapy and temozolomide)

Eligibility Criteria

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

You may qualify if:

• Willing and capable of undergoing apheresis for collection of mononuclear cells
• Histologically confirmed GBM (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
• Platelets (PLT) \>= 100,000 / uL
• Hemoglobin (HgB) \>= 9.0 g/dL
• Total bilirubin =\< 1.5 x upper normal limit (UNL)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3 x UNL
• Creatinine =\< 1 x UNL
• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
• Ability to understand and willingness to sign a written informed consent
• Willing to return to Mayo Clinic Rochester 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
• Completed standard external beam radiation with temozolomide

You may not qualify if:

• Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
• Any of the following
• Pregnant women
• Nursing women
• Men or women 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 including treated lower grade gliomas; EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or lower grade glioma that has never been treated previously; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
• History of myocardial infarction =\< 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Active infection =\< 5 days prior to registration or fever \> 38 degrees Celsius (C) on day of registration
• History of tuberculosis or positive purified protein derivative (PPD) test
• Inability or unwillingness to have magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

Temozolomide

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: October 4, 2013
• First Posted: October 8, 2013
• Study Start: November 11, 2013
• Primary Completion: November 16, 2016
• Study Completion: November 16, 2016
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)