Status:
TERMINATED
MnSOD (Esophageal Protectant) to Prevent Esophagitis During Radiation/Chemotherapy Treatment for Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Joel Greenberger
Conditions:
Esophageal
Toxicity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 concurre...
Detailed 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 concurre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 11 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00618917
Start Date
November 11 2005
End Date
August 11 2011
Last Update
November 12 2021
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232