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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

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ammonium tetrathiomolybdate
immunoenzyme technique
laboratory biomarker analysis
Tc 99m sestamibi
radiation therapy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Acute toxicity

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2007
Last Updated
September 30, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00560495
Brief Title
Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ammonium tetrathiomolybdate
Intervention Description
4 times daily for up to 3 weeks
Intervention Type
Other
Intervention Name(s)
immunoenzyme technique
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Radiation
Intervention Name(s)
Tc 99m sestamibi
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
once daily, 5 days a week, for 6-7 weeks
Primary Outcome Measure Information:
Title
Acute toxicity
Secondary Outcome Measure Information:
Title
Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)
Title
Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans
Title
Late toxicity
Title
Collection of response, recurrence, and survival data
Time Frame
every 3 months for up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad K. Khan, MD, PhD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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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

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