NCT01957956

Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

Completed EARLY_PHASE1 Last updated 18 November 2023

What this trial tests

EARLY_PHASE1 trial testing Laboratory Biomarker Analysis in Giant Cell Glioblastoma in 21 participants. Completed in 16 November 2016.

Timeline

11 November 2013

Primary endpoint
16 November 2016

16 November 2016

Quick facts

Lead sponsor	Mayo Clinic
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	11 November 2013
Primary completion	16 November 2016
Estimated completion	16 November 2016
Sites	1 location across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine — full drug profile →
• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• Giant Cell Glioblastoma — all drugs for Giant Cell Glioblastoma →
• Glioblastoma — all drugs for Glioblastoma →
• Gliosarcoma — all drugs for Gliosarcoma →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Giant Cell Glioblastoma or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
2. Personalized Dendritic Cell Vaccines-Recent Breakthroughs and Encouraging Clinical Results.
   Mastelic-Gavillet B, Balint K, Boudousquie C, Gannon PO, et al · · 2019 · cited 145× · PMID 31031762 · DOI 10.3389/fimmu.2019.00766
3. Advances in Glioblastoma Therapy: An Update on Current Approaches.
   Angom RS, Nakka NMR, Bhattacharya S. · · 2023 · cited 140× · PMID 38002496 · DOI 10.3390/brainsci13111536
4. Research progress on dendritic cell vaccines in cancer immunotherapy.
   Yu J, Sun H, Cao W, Song Y, et al · · 2022 · cited 130× · PMID 35074008 · DOI 10.1186/s40164-022-00257-2
5. Immunotherapy Based on Dendritic Cell-Targeted/-Derived Extracellular Vesicles-A Novel Strategy for Enhancement of the Anti-tumor Immune Response.
   Markov O, Oshchepkova A, Mironova N. · · 2019 · cited 96× · PMID 31680949 · DOI 10.3389/fphar.2019.01152
6. Immune Escape in Glioblastoma Multiforme and the Adaptation of Immunotherapies for Treatment.
   Pearson JRD, Cuzzubbo S, McArthur S, Durrant LG, et al · · 2020 · cited 92× · PMID 33178210 · DOI 10.3389/fimmu.2020.582106
7. Immunotherapy for primary brain tumors: no longer a matter of privilege.
   Fecci PE, Heimberger AB, Sampson JH. · · 2014 · cited 83× · PMID 25398845 · DOI 10.1158/1078-0432.ccr-14-0832
8. Glioblastoma Immunotherapy: A Systematic Review of the Present Strategies and Prospects for Advancements.
   Agosti E, Zeppieri M, De Maria L, Tedeschi C, et al · · 2023 · cited 69× · PMID 37894718 · DOI 10.3390/ijms242015037