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

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00560495

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: Tc 99m sestamibi Drug: ammonium tetrathiomolybdate Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: radiation therapy	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Tetrathiomolybdate Technetium Tc 99m sestamibi

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2007
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

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

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

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000574135, RPCI-EPR-38104
Study First Received:	November 16, 2007
Last Updated:	December 25, 2008
ClinicalTrials.gov Identifier:	NCT00560495
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Tetrathiomolybdate
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Molybdenum
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Trace Elements
Enzyme Inhibitors
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Micronutrients
Chelating Agents
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009