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NCT03477110

Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma

Completed EARLY_PHASE1 Last updated 15 May 2025
What this trial tests

EARLY_PHASE1 trial testing Temozolomide in Glioblastoma in 30 participants. Completed in 26 January 2024.

Timeline
4 May 2018
Primary endpoint
21 April 2021
26 January 2024

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date4 May 2018
Primary completion21 April 2021
Estimated completion26 January 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

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

Sponsor's own description

This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.

Publications & conference data

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

  1. Treatment of Glioblastoma (GBM) with the Addition of Tumor-Treating Fields (TTF): A Review.
    Fabian D, Guillermo Prieto Eibl MDP, Alnahhas I, Sebastian N, et al · · 2019 · cited 163× · PMID 30717372 · DOI 10.3390/cancers11020174
  2. Tumor Treating Fields in the Management of Patients with Malignant Gliomas.
    Ghiaseddin AP, Shin D, Melnick K, Tran DD. · · 2020 · cited 79× · PMID 32734509 · DOI 10.1007/s11864-020-00773-5
  3. Exploring the efficacy of tumor electric field therapy against glioblastoma: An in vivo and in vitro study.
    Wu H, Yang L, Liu H, Zhou D, et al · · 2021 · cited 38× · PMID 34710276 · DOI 10.1111/cns.13750
  4. Tumor Treating Fields: At the Crossroads Between Physics and Biology for Cancer Treatment.
    Carrieri FA, Smack C, Siddiqui I, Kleinberg LR, et al · · 2020 · cited 29× · PMID 33215030 · DOI 10.3389/fonc.2020.575992
  5. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma.
    Miller R, Song A, Ali A, Niazi M, et al · · 2022 · cited 22× · PMID 35574391 · DOI 10.3389/fonc.2022.896246
  6. Initial experience with scalp sparing radiation with concurrent temozolomide and tumor treatment fields (SPARE) for patients with newly diagnosed glioblastoma.
    Song A, Bar-Ad V, Martinez N, Glass J, et al · · 2020 · cited 22× · PMID 32206976 · DOI 10.1007/s11060-020-03466-z
  7. Recent advances in Tumor Treating Fields (TTFields) therapy for glioblastoma.
    Khagi S, Kotecha R, Gatson NTN, Jeyapalan S, et al · · 2025 · cited 20× · PMID 39401002 · DOI 10.1093/oncolo/oyae227
  8. Enhancing glioblastoma treatment through the integration of tumor-treating fields.
    Szklener K, Bilski M, Nieoczym K, Mańdziuk D, et al · · 2023 · cited 20× · PMID 37916157 · DOI 10.3389/fonc.2023.1274587

Verify or expand the search:

Other trials of Temozolomide

Trials testing the same drug.

Other recruiting trials for Glioblastoma

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials

Trials by the same sponsor.

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