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This study has been withdrawn prior to enrollment.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
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
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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: 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:
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| 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
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 Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Therapeutic Uses Chelating Agents Trace Elements Micronutrients |
ClinicalTrials.gov processed this record on June 17, 2013