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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00560495
• Other study ID #: CDR0000574135
• Secondary ID: RPCI-EPR-38104
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: September 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• ammonium tetrathiomolybdate
4 times daily for up to 3 weeks

Other:
• immunoenzyme technique

• laboratory biomarker analysis

Radiation:
• Tc 99m sestamibi

• radiation therapy
once daily, 5 days a week, for 6-7 weeks

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity
Secondary	Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)
Secondary	Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans
Secondary	Late toxicity
Secondary	Collection of response, recurrence, and survival data		every 3 months for up to 2 years