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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT00618917
• Date of registration: 06/02/2008
• Primary sponsor: University of Pittsburgh
• Public title: MnSOD (Esophageal Protectant) to Prevent Esophagitis During Radiation/Chemotherapy Treatment for Non-Small Cell Lung Cancer (NSCLC) MnSOD
• Scientific 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
• Date of first enrolment: November 2005
• Target sample size: 45
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00618917
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ahmad Tarhini, MD
• Affiliation: University of Pittsburgh Cancer Institute/Univeristy of Pittsburgh Medical Center, Cancer Centers

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Esophageal

Toxicity

Intervention(s)

Genetic: MnSOD

Primary Outcome(s)

Biologic endpoints [Time Frame: Characterization of esophageal biopsy specimens by immunohistochemistry, RT-PCR for MnSOD mRNA as a measure of gene transfection and expression levels of inflammatory cytokines]

Efficacy [Time Frame: The clinical endpoint will be the proportion of radiation - induced grade III/IV esophageal toxicity.]

feasibility and safety [Time Frame: The endpoint will be the proportion of toxicities attributed to administration of MnSOD plasmid liposome.]

Secondary Outcome(s)

clinical response to the combination of chemoradiotherapy with esophagus protection by MnSOD plasmid/liposome. [Time Frame: dependent on subject response and survivial status]

Secondary ID(s)

01-054

UPCI 01-054

Source(s) of Monetary Support

Please refer to primary and secondary sponsors