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WithdrawnPhase 1NCT00560495
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedammonium tetrathiomolybdate and immunoenzyme technique

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 3, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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