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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute toxicity

Safety Issue:

Yes

Principal Investigator

Mohammad K. Khan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000574135

NCT ID:

NCT00560495

Start Date:

May 2007

Completion Date:

July 2008

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263