TerminatedPhase 1 / Phase 2NCT00618917

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

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).

Checked against the public recordLast updated Nov 12, 2021 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations1
SponsorJoel Greenberger
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Joel Greenberger
Interventions being studied
Genetic: Manganese Superoxide Dismutase Plasmid Liposome; Drug: carboplatin; Drug: paclitaxel; Radiation: Radiation Therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically or cytologically documented NSCLC including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated non-small cell lung cancer. Totally resected tumors are excluded. * Subjects must be without evidence of M0. * Subjects with T1 or T2 disease with N2 or tumor stage 3, lymph node metastasis 1-2 ( stage 1) disease (Stage IIIA) are eligible if they are medically inoperable. Subjects with T4 with any N or any T with N3 disease are eligible. Radiographic evidence of mediastinal lymph nodes \>2.0 cm in the largest diameter is sufficient to stage N2 or N3 disease. If the largest mediastinal node is \< 2.0 cm in diameter and this is the basis for stage III disease, then at least one of the nodes must be proven positive cytologically or histologically. * Subjects with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to \< 50% of the ipsilateral lung volume. * Subjects with a pleural effusion that is a transudate, cytologically negative and non-bloody are eligible if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy. Exudative, bloody, or cytologically malignant effusions are ineligible. If a pleural effusion can be seen on the chest CT but not on chest X-ray and is too small to tap, the subject will be eligible. * Subjects must be deemed a suitable candidate for protocol treatment by both Radiation Oncology and Medical Oncology * Subjects must have a Performance Status \> 70 (Karnofsky Performance Scale). * Subjects Weight loss \< 10% in 3 months prior to diagnosis. * Subjects must be male or female \> 18 years. * Subjects must have had no prior systemic chemotherapy, radiation therapy to the thorax, or total surgical resection. * At least 3 weeks since formal exploratory thoracotomy and the subject has recovered from surgery, or 1 week from diagnostic thoracoscopy. * Laboratory values must be as follows: (See Section 6.1 of the full protocol for required timing): Granulocytes \> 2,000/ml, Platelets \> 100,000/ml, Hemoglobin\* \> 8 mg/dl, Bilirubin \< 1.5 x normal, Creatinine clearance \> 50 ml/n (24 hour or calculated, forced expiratory volume at one second \> 800 cc. Note: \*Physician can maintain a subject's hemoglobin with the use of Erythropoetin or transfusions prophylactic use of G-CSF (colony stimulating factor, is not permitted). * Subjects must have a MRI or CT brain scan within 4 weeks prior to study entry to rule out asymptomatic brain metastases. * Subjects must be informed of the investigational nature of the study and sign an informed consent form and have no serious medical or psychiatric illnesses that would prevent informed consent. * No history of serious cardiac disease that is not adequately controlled. * Female subjects must be non-pregnant and non-lactating. Female subjects of childbearing potential must implement an effective method of contraception during the study. All women of childbearing potential must have a pre-study negative serum or urine pregnancy test within 7 days prior to study entry. Exclusion Criteria * Inability to meet any of the above eligibility requirements

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of PittsburghPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 12, 2021. Always confirm current availability with the study team.

View original record ↗