α-TEA in Advanced Cancer

Status Completed

Clinical Trial Summary

The goal of this study is to find the highest dose of α-TEA that can be given to patients safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in patients' blood.

Additional goals of this study are to monitor the effect on tumors, to check for specific immune cells circulating in the blood, and to see if there are certain features of tumors that make it possible to predict the response to α-TEA.

Clinical Trial Description

This is a dose-escalation study in which doses ranging from 2.4 mg/kg to 26.8 mg/kg of α-TEA will be tested.

The main clinical objectives of this phase I two-stage dose-escalation trial will be to characterize α-TEA related toxicity, determine the maximum tolerated dose, and pharmacokinetics of α-TEA in humans. Tumor response and exploratory immunological monitoring will also be performed. Specifically, we will determine the frequency of circulating peripheral T cell subset populations including CD4+, CD8+ T cells and their activation status (central memory, effector cells) and regulatory T cells (CD4/CD25/Foxp3). Exploratory monitoring to assess tumor apoptosis and serum cytokine levels will also be performed to gain additional insight on the influence of α-TEA on the immune response and tumor. An assessment of the immunoscore in patients with tumor amenable to biopsy will also provide hypothesis-generating data on the influence of α-TEA on the tumor microenvironment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02192346
Study type	Interventional
Source	Providence Health & Services
Contact
Status	Completed
Phase	Phase 1
Start date	August 4, 2014
Completion date	May 8, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04457258` - 68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma	Early Phase 1
Withdrawn	`NCT04906876` - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas	Phase 2
Completed	`NCT01106872` - Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas	Phase 1
Terminated	`NCT03520959` - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)	Phase 3
Completed	`NCT01112384` - A Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas	Phase 2
Completed	`NCT03357315` - Mix Vaccine for Metastatic Sarcoma Patients	Phase 1/Phase 2
Active, not recruiting	`NCT05448820` - YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma	Phase 1/Phase 2
Active, not recruiting	`NCT04595747` - Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)	Phase 2
Not yet recruiting	`NCT06298916` - 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer	Phase 1/Phase 2
Recruiting	`NCT04693377` - Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial	N/A
Recruiting	`NCT03168061` - Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma	Phase 1/Phase 2
Not yet recruiting	`NCT05835154` - A Checklist (Advanced Care Planning) for The Assessment of Mobility Needs in Patients With Sarcoma	N/A
Not yet recruiting	`NCT04199026` - Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma	Early Phase 1
Not yet recruiting	`NCT06235125` - Safety and Feasibility of Intraoperative Visualization With Cytalux in Children	Phase 1
Recruiting	`NCT04771520` - Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors	Phase 2
Recruiting	`NCT05711615` - Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma	Phase 1
Completed	`NCT03823144` - Intravital Microscopy in Human Solid Tumors	N/A
Recruiting	`NCT04430725` - Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Completed	`NCT02448537` - A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas	Phase 2
Terminated	`NCT02609984` - Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)	Phase 2