NCT04397679

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

Terminated Phase 1 Last updated 15 January 2025

What this trial tests

Phase 1 trial testing 3-Dimensional Conformal Radiation Therapy in Glioblastoma in 2 participants. Terminated before completion.

Timeline

12 August 2021

Primary endpoint
14 May 2024

14 May 2024

Quick facts

Lead sponsor	Barbara Ann Karmanos Cancer Institute
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	12 August 2021
Primary completion	14 May 2024
Estimated completion	14 May 2024
Sites	1 location across United States

Drugs / interventions tested

• 3-Dimensional Conformal Radiation Therapy
• Intensity-Modulated Radiation Therapy (IMRT)
• Temozolomide (temozolomide) — full drug profile →
• Chloroquine (CHLOROQUINE) — full drug profile →
• Tumor Treating Fields Therapy (TTF)

Conditions studied

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

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

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

Sponsor's own description

This trial studies the side effects of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy for the treatment of newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chloroquine is normally used to treat strains of malaria and prior preclinical and clinical data suggests that it may increase the efficacy of both radiation and tumor treating fields therapy. Tumor treating fields therapy uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. The purpose of this study is to determine the safety of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy in patients with gliobastoma

Publications & conference data

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

1. Radiotherapy as a tool to elicit clinically actionable signalling pathways in cancer.
   Petroni G, Cantley LC, Santambrogio L, Formenti SC, et al · · 2022 · cited 154× · PMID 34819622 · DOI 10.1038/s41571-021-00579-w
2. Chloroquine against malaria, cancers and viral diseases.
   Zhou W, Wang H, Yang Y, Chen ZS, et al · · 2020 · cited 85× · PMID 32947043 · DOI 10.1016/j.drudis.2020.09.010
3. Autophagy Modulators in Cancer Therapy.
   Buzun K, Gornowicz A, Lesyk R, Bielawski K, et al · · 2021 · cited 50× · PMID 34071600 · DOI 10.3390/ijms22115804
4. Autophagy Takes Center Stage as a Possible Cancer Hallmark.
   Alvarez-Meythaler JG, Garcia-Mayea Y, Mir C, Kondoh H, et al · · 2020 · cited 40× · PMID 33194736 · DOI 10.3389/fonc.2020.586069
5. Tumor-Treating Fields in Glioblastomas: Past, Present, and Future.
   Guo X, Yang X, Wu J, Yang H, et al · · 2022 · cited 39× · PMID 35954334 · DOI 10.3390/cancers14153669
6. Targeting Cytoprotective Autophagy to Enhance Anticancer Therapies.
   Xiao M, Benoit A, Hasmim M, Duhem C, et al · · 2021 · cited 29× · PMID 33718194 · DOI 10.3389/fonc.2021.626309
7. Enhancing Anti-Cancer Therapy with Selective Autophagy Inhibitors by Targeting Protective Autophagy.
   Lee MJ, Park JS, Jo SB, Joe YA. · · 2023 · cited 28× · PMID 36579459 · DOI 10.4062/biomolther.2022.153
8. Blockage of Autophagy for Cancer Therapy: A Comprehensive Review.
   Hassan AMIA, Zhao Y, Chen X, He C. · · 2024 · cited 26× · PMID 39000565 · DOI 10.3390/ijms25137459