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

NCT ID: NCT00560495

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-07-31

Brief 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.

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ammonium tetrathiomolybdate

4 times daily for up to 3 weeks

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Tc 99m sestamibi

Intervention Type: RADIATION

radiation therapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad K. Khan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-EPR-38104

Identifier Type: -

Identifier Source: secondary_id

CDR0000574135

Identifier Type: -

Identifier Source: org_study_id