NCT00892385

Methoxyamine and Temozolomide in Treating Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 22 February 2019

What this trial tests

Phase 1 trial testing Methoxyamine in Unspecified Adult Solid Tumor, Protocol Specific in 66 participants. Completed in 8 March 2017.

Timeline

16 August 2007

Primary endpoint
8 March 2017

8 March 2017

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	16 August 2007
Primary completion	8 March 2017
Estimated completion	8 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Methoxyamine — full drug profile →
• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Unspecified Adult Solid Tumor, Protocol Specific. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving methoxyamine together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of methoxyamine when given together with temozolomide in treating patients with advanced solid tumors.

Publications & conference data

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

1. DNA Repair Pathways in Cancer Therapy and Resistance.
   Li LY, Guan YD, Chen XS, Yang JM, et al · · 2020 · cited 254× · PMID 33628188 · DOI 10.3389/fphar.2020.629266
2. Dynamic Regulation of APE1/Ref-1 as a Therapeutic Target Protein.
   Choi S, Joo HK, Jeon BH. · · 2016 · cited 36× · PMID 27231670 · DOI 10.4068/cmj.2016.52.2.75
3. IDO Downregulation Induces Sensitivity to Pemetrexed, Gemcitabine, FK866, and Methoxyamine in Human Cancer Cells.
   Maleki Vareki S, Chen D, Di Cresce C, Ferguson PJ, et al · · 2015 · cited 29× · PMID 26579709 · DOI 10.1371/journal.pone.0143435
4. A versatile new tool to quantify abasic sites in DNA and inhibit base excision repair.
   Wei S, Shalhout S, Ahn YH, Bhagwat AS. · · 2015 · cited 28× · PMID 25616257 · DOI 10.1016/j.dnarep.2014.12.006
5. Inhibition of APE1/Ref-1 for Neovascular Eye Diseases: From Biology to Therapy.
   Hartman GD, Lambert-Cheatham NA, Kelley MR, Corson TW. · · 2021 · cited 20× · PMID 34638620 · DOI 10.3390/ijms221910279
6. Phase I clinical trial of temozolomide and methoxyamine (TRC-102), an inhibitor of base excision repair, in patients with advanced solid tumors.
   Eads JR, Krishnamurthi SS, Saltzman J, Bokar JA, et al · · 2021 · cited 13× · PMID 32556884 · DOI 10.1007/s10637-020-00962-x
7. Evaluating the Base Excision Repair Inhibitor TRC102 and Temozolomide for Patients with Recurrent Glioblastoma in the Phase 2 Adult Brain Tumor Consortium Trial BERT.
   Ahluwalia MS, Ozair A, Drappatz J, Ye X, et al · · 2024 · cited 5× · PMID 38836759 · DOI 10.1158/1078-0432.ccr-23-4098
8. Revisiting Temozolomide's role in solid tumors: Old is gold?
   Matthaios D, Balgkouranidou I, Neanidis K, Sofis A, et al · · 2024 · cited 5× · PMID 38817857 · DOI 10.7150/jca.94109