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
- 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.
- 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
- To collect tumor response, recurrence rate, and survival data on these patients.
- 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
After completion of study therapy, patients are followed every 3 months for up to 2 years.
Masking: Open Label, Primary Purpose: Treatment
Mohammad K. Khan, MD, PhD
Roswell Park Cancer Institute
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|