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

September 30, 2022 updated by: Roswell Park Cancer Institute

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Acute toxicity

Secondary Outcome Measures

Outcome Measure
Time 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 data
Time Frame: every 3 months for up to 2 years
every 3 months for up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Mohammad K. Khan, MD, PhD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (ESTIMATE)

November 19, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574135
  • RPCI-EPR-38104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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