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This study has been withdrawn prior to enrollment.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:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00560495
First Posted: November 19, 2007
Last Update Posted: February 10, 2012
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
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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: None (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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Roswell Park Cancer Institute:
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 [ Time Frame: every 3 months for up to 2 years ]
| 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:
Detailed Description:
-
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
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560495
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Mohammad K. Khan, MD, PhD | Roswell Park Cancer Institute |
More Information
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00560495 History of Changes |
| Other Study ID Numbers: |
CDR0000574135 P30CA016056 ( U.S. NIH Grant/Contract ) RPCI-EPR-38104 |
| First Submitted: | November 16, 2007 |
| First Posted: | November 19, 2007 |
| Last Update Posted: | February 10, 2012 |
| Last Verified: | February 2012 |
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:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Technetium Tc 99m Sestamibi Tetrathiomolybdate Molybdenum |
Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action Chelating Agents Sequestering Agents Enzyme Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Trace Elements Micronutrients |