Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ammonium tetrathiomolybdate | Drug | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| Tc 99m sestamibi | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Acute toxicity
Secondary outcomes (4)
- measure
- Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)
- measure
- Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans
- measure
- Late toxicity
- measure
- Collection of response, recurrence, and survival data
- timeFrame
- every 3 months for up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 chemotherapyReferences
Publications (0)
Data not yet available