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

The Combination of Radiotherapy With the Anti-Angiogenic Agent Tetrathiomolybdate (TM) in the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase I Study

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00560495
Enrollment
0
Registered
2007-11-19
Start date
2007-05-31
Completion date
2008-07-31
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

OBJECTIVES: Primary * To assess the acute toxicity of combining antiangiogenic copper reduction with ammonium tetrathiomolybdate (TM) and standard external-beam radiotherapy in patients with stage I-IIIB non-small cell lung cancer. Secondary * To measure changes in biological markers of angiogenesis (i.e., ELISA analysis of serum bFGF, VEGF, TGF-beta, IL-6, and IL-8) affected by TM or radiotherapy and an imaging technique (technetium 99m sestamibi) known to correlate with intratumoral angiogenesis. * To follow the late toxicity that exists when angiogenic inhibition with the copper reduction agent TM is combined with standard external-beam radiotherapy in these patients. * To collect tumor response, recurrence rate, and survival data on these patients. OUTLINE: * Induction phase: Patients receive oral ammonium tetrathiomolybdate (TM) 4 times daily for up to 3 weeks. * Radiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6-7 weeks along with concurrent TM. * Maintenance phase: Patients continue to receive TM for a total of 1 year . Blood is collected periodically for analysis of laboratory outcomes by ELISA and technetium 99m sestamibi scans. Biomarkers may include VEGF, bFGF, TGF-beta, interleukin (IL)-6, and IL-8. After completion of study therapy, patients are followed every 3 months for up to 2 years.

Interventions

DRUGammonium tetrathiomolybdate

4 times daily for up to 3 weeks

OTHERimmunoenzyme technique
OTHERlaboratory biomarker analysis
RADIATIONradiation therapy

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

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Acute toxicity

Secondary

MeasureTime frame
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 dataevery 3 months for up to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026