Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00560495|
Recruitment Status : Withdrawn
First Posted : November 19, 2007
Last Update Posted : February 10, 2012
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 or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: ammonium tetrathiomolybdate Other: immunoenzyme technique Other: laboratory biomarker analysis Radiation: Tc 99m sestamibi Radiation: radiation therapy||Phase 1|
- 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 patients.
- 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 IL-8.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
- Drug: ammonium tetrathiomolybdate
4 times daily for up to 3 weeks
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
- Radiation: Tc 99m sestamibi
- Radiation: radiation therapy
once daily, 5 days a week, for 6-7 weeks
- Acute toxicity
- Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)
- Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans
- Late toxicity
- Collection of response, recurrence, and survival data [ Time Frame: every 3 months for up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560495
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Mohammad K. Khan, MD, PhD||Roswell Park Cancer Institute|