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

NCT00560495 | Withdrawn Phase 1

• 2 other identifiers: CDR0000574135RPCI-EPR-38104
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; large cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

Secondary Outcomes (4)

• Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)

• Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans

• Late toxicity

• Collection of response, recurrence, and survival data

  every 3 months for up to 2 years

Interventions

ammonium tetrathiomolybdate DRUG

4 times daily for up to 3 weeks

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

Tc 99m sestamibi RADIATION

radiation therapy RADIATION

once daily, 5 days a week, for 6-7 weeks

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

tetrathiomolybdate; Immunoenzyme Techniques; Technetium Tc 99m Sestamibi; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques; Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds; Therapeutics

Study Officials

• Mohammad K. Khan, MD, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

US (1)