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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00560495
First received: November 16, 2007
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: ammonium tetrathiomolybdate
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Radiation: Tc 99m sestamibi
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Acute toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8) [ Designated as safety issue: No ]
  • Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans [ Designated as safety issue: No ]
  • Late toxicity [ Designated as safety issue: Yes ]
  • Collection of response, recurrence, and survival data [ Time Frame: every 3 months for up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ammonium tetrathiomolybdate
    4 times daily for up to 3 weeks
    Other: immunoenzyme technique Other: laboratory biomarker analysis Radiation: Tc 99m sestamibi Radiation: radiation therapy
    once daily, 5 days a week, for 6-7 weeks
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560495

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Mohammad K. Khan, MD, PhD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00560495     History of Changes
Other Study ID Numbers: CDR0000574135, P30CA016056, RPCI-EPR-38104
Study First Received: November 16, 2007
Last Updated: February 8, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Tetrathiomolybdate
Molybdenum
Technetium Tc 99m Sestamibi
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Trace Elements
Micronutrients
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 22, 2014