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This study has been withdrawn prior to enrollment.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

November 16, 2007
February 8, 2012
May 2007
July 2008   (final data collection date for primary outcome measure)
Acute toxicity [ Designated as safety issue: Yes ]
Acute toxicity
Complete list of historical versions of study NCT00560495 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560495
CDR0000574135, P30CA016056, RPCI-EPR-38104
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Mohammad K. Khan, MD, PhD Roswell Park Cancer Institute
Roswell Park Cancer Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP