Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Molybdenum; Technetium Tc 99m Sestamibi; Tetrathiomolybdate

Criteria

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