NCT00770471

ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed Phase 1 Last updated 27 June 2018

What this trial tests

Phase 1 trial testing temozolomide in Brain and Central Nervous System Tumors in 24 participants. Completed in 1 March 2012.

Timeline

13 July 2009

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	13 July 2009
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	11 locations across United States

Drugs / interventions tested

• temozolomide (temozolomide) — full drug profile →
• veliparib
• DNA methylation analysis
• gene expression analysis
• mutation analysis
• proteomic profiling
• high performance liquid chromatography
• immunoenzyme technique
• laboratory biomarker analysis — full drug profile →
• mass spectrometry — full drug profile →
• pharmacogenomic studies
• pharmacological study — full drug profile →
• adjuvant therapy — full drug profile →
• radiation therapy

Conditions studied

• Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 120, any sex, with Brain and Central Nervous System Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays 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 ABT-888 together with radiation therapy and temozolomide may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-888 when given together with radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed glioblastoma multiforme.

Publications & conference data

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

1. Glioblastoma multiforme (GBM): An overview of current therapies and mechanisms of resistance.
   Wu W, Klockow JL, Zhang M, Lafortune F, et al · · 2021 · cited 532× · PMID 34302977 · DOI 10.1016/j.phrs.2021.105780
2. Targeting DNA damage response in cancer therapy.
   Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
3. Harnessing synthetic lethal interactions in anticancer drug discovery.
   Chan DA, Giaccia AJ. · · 2011 · cited 195× · PMID 21532565 · DOI 10.1038/nrd3374
4. Pathway inhibition: emerging molecular targets for treating glioblastoma.
   Wick W, Weller M, Weiler M, Batchelor T, et al · · 2011 · cited 103× · PMID 21636705 · DOI 10.1093/neuonc/nor039
5. Restoration of Temozolomide Sensitivity by PARP Inhibitors in Mismatch Repair Deficient Glioblastoma is Independent of Base Excision Repair.
   Higuchi F, Nagashima H, Ning J, Koerner MVA, et al · · 2020 · cited 92× · PMID 31900275 · DOI 10.1158/1078-0432.ccr-19-2000
6. A phase I/II study of veliparib (ABT-888) with radiation and temozolomide in newly diagnosed diffuse pontine glioma: a Pediatric Brain Tumor Consortium study.
   Baxter PA, Su JM, Onar-Thomas A, Billups CA, et al · · 2020 · cited 76× · PMID 32009149 · DOI 10.1093/neuonc/noaa016
7. Poly(ADP-Ribose)Polymerase (PARP) Inhibitors and Radiation Therapy.
   Jannetti SA, Zeglis BM, Zalutsky MR, Reiner T. · · 2020 · cited 66× · PMID 32194409 · DOI 10.3389/fphar.2020.00170
8. Temozolomide chronotherapy in patients with glioblastoma: a retrospective single-institute study.
   Damato AR, Luo J, Katumba RGN, Talcott GR, et al · · 2021 · cited 61× · PMID 33959716 · DOI 10.1093/noajnl/vdab041