Clinical Trials Logo
  1. Home
  2. Toxicity
  3. NCT00618917

MnSOD (Esophageal Protectant) to Prevent Esophagitis During Radiation/Chemotherapy Treatment for Non-Small Cell Lung Cancer (NSCLC) — MnSOD  

Toxicity Clinical Trial

Official title:
Chemotherapy (Paclitaxel and Carboplatin)and Thoracic Radiotherapy With Swallowed Manganese Superoxide Dismutase (MnSOD) Plasmid Liposome Protection in Patients With Locally Advanced Stage III Non-Small Cell Lung Cancer: A Phase I-II Study

Clinical Trial Summary

This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung cancer (NSCLC).

Clinical Trial Description

This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung cancer (NSCLC). Phase I of the study will assess the feasibility and safety of MnSOD PL by dose escalation in 3 cohorts of 3 chemoradiotherapy subjects each (Cohort1 = 0.3 mg/dose, Cohort2 = 3 mg/dose, Cohort3 = 30 mg/dose). The highest dose completed (as determined by toxicity monitoring for 8 weeks from initial treatment) will be the starting dose for Phase II. Phase II will examine the efficacy of MnSOD PL by assessing the incidence of Grade 3 or 4 esophagitis in 27 additional chemoradiotherapy subjects. Incidence of esophageal toxicity, as well as clinical response to the combination of chemoradiotherapy with MnSOD PL are the outcomes of interest. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00618917
Study type Interventional
Source University of Pittsburgh
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date November 11, 2005
Completion date August 11, 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT02273713 - The Addition of Nab-paclitaxel (Abraxane) to First Line Treatment of Metastasized Oesophagogastric Carcinoma (ACTION) Phase 1/Phase 2
Terminated NCT00531076 - Safety Study of Bevacizumab (Avastin) With Thoracic Radiation in Non-small Cell Cell Lung Cancer Phase 1
Active, not recruiting NCT02397434 - Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer N/A
Withdrawn NCT03342300 - Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine in Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma Phase 2/Phase 3
Active, not recruiting NCT02649491 - Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy N/A
Active, not recruiting NCT03975452 - Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer N/A
Not yet recruiting NCT02760823 - Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning Phase 2
Completed NCT02864030 - PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment Phase 4
Completed NCT00890448 - Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate N/A
Terminated NCT01760356 - Study of PD/PK/PG Relationships of Tacrolimus and Cyclosporin in Liver Transplant Patients
Recruiting NCT06044623 - Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients Phase 3
Completed NCT01091766 - Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine Phase 4
Completed NCT05277480 - Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE) Phase 2
Recruiting NCT03978949 - Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP) Phase 3
Completed NCT03491371 - Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use N/A
Completed NCT02143219 - Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer Phase 2
Completed NCT02054741 - Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer N/A
Not yet recruiting NCT06087718 - Feasibility of the Maastro Applicator in Rectal Cancer N/A
Terminated NCT02512809 - Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Phase 3
Completed NCT03612544 - The ESTxENDS Trial- Substudy on the Effect on Toxins From Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) N/A