Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving radiation therapy together with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Checked against the public recordLast updated Oct 3, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Roswell Park Cancer Institute
- Interventions being studied
- Drug: ammonium tetrathiomolybdate; Other: immunoenzyme technique; Other: laboratory biomarker analysis; Radiation: Tc 99m sestamibi; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria: * Squamous, large cell undifferentiated, or adenocarcinoma * Sputum cytology not acceptable evidence of cell type * Cytologic specimens obtained by brushing, washing, or needle aspiration of a defined lesion allowed * Stage I-IIIB disease * No evidence of distant metastases * Planning to receive definitive radiotherapy alone or post-operative radiotherapy (for gross residual disease or positive margin) * Medically inoperable disease or chemotherapy or surgery refused * Mediastinal lymph nodes must be evaluated by either mediastinoscopy or by PET scan, unless definitive CT-positive mediastinal disease is noted * If patient cannot tolerate mediastinoscopy and no PET is available, the technetium 99m sestamibi scan is allowed for assessment of the mediastinum * No stage IIIB disease with pleural effusions or stage IV disease * No small cell lung cancer or mixed small cell/non-small cell histology PATIENT CHARACTERISTICS: * SWOG performance status 0-2 * Hemoglobin ≥ 9.0 g/dL * WBC ≥ 3,000/mm³ * ANC ≥ 1,200/mm³ * Platelet count ≥ 80,000/mm³ * Creatinine \< 1.8 mg/dL * Prior malignancy allowed if disease free for ≥ 5 years * Nonmelanoma skin cancer allowed within 5 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No grade 3 hemoptysis (or hemoptysis not requiring transfusion, but where the radiation oncologist has concerns about a 3-week delay in treatment) * No pneumonia due to bronchial obstruction (or a high-grade bronchial obstruction where the radiation oncologist has concerns about a 3-week delay in treatment) * No transfusion dependence requiring \> 2 units of packed RBCs every 2 weeks for more than 28 days * No medically serious acute or chronic medical condition that is unstable and/or requires intensive management PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior thoracic radiation allowed if the new lesion can be treated with absolutely no overlap of previous treatment fields * At least 3 weeks since prior surgery * No concurrent chemotherapy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Roswell Park Cancer InstituteBuffalo, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 3, 2022. Always confirm current availability with the study team.