Phase I Trial of ECI301 in Combination With Radiation in Patients With Advanced or Metastatic Cancer
- Patients with metastatic or locally advanced cancer frequently require palliative
radiotherapy to relieve symptoms; however, progression of disease is frequent in
patients with extended survival
- Radiation results in tumor cell death which can result in increased dendritic cell
activation and trafficking
- ECI301 is a derivative of Macrophage Inflammatory Protein-1?, a 70 amino acid chemokine
that is a ligand for CCR1 and CCR5, the chemokine receptors of immature dendritic
- ECI301 has been shown to enhance the effect of radiotherapy in animal models.
- The primary objective is to determine the maximum tolerated dose (MTD) of ECI301
delivered in combination with 30 Gy of external beam radiation to patients with
metastatic or locally advanced cancer.
- The secondary objectives are:
- To describe the safety and tolerability of ECI301 delivered in combination with 30
Gy of external beam radiation to patients with metastatic or locally advanced
- To evaluate the humoral and cellular immune responses by:
- Measurement of circulating precursor dendritic cells before and after the
completion of ECI301
- Measurement of circulating MIP-? before and after the completion of ECI301
- Assessment of T-lymphocyte quantitative and qualitative changes by flow
cytometry and assays for IFN? production
- To define pharmacologic parameters following the intravenous dose of ECI301
- To determine if neutralizing anti-EC301 antibodies occur after treatment
- To describe the response at the radiated site and distant sites after radiation in
combination with ECI301
- Age > 18 years.
- ECOG performance status < 2.
- Life expectancy of greater than 3 months
- Histologically confirmed metastatic or locally advanced cancer for which
radiotherapeutic management would be appropriate
- No recent history of myocardial infarction or unstable angina
- This is a Phase I trial to determine the maximum tolerated dose of ECI301 in
combination with external beam radiation therapy in patients with locally advanced or
metastatic solid tumors.
- Patients will be treated with radiation therapy in a standard manner with ECI301 given
daily during radiation. The dose of ECI301 will be escalated over the course of the
trial to determine the MTD of daily ECI301 in combination with radiotherapy.
- We anticipate that accrual to this trial of 30 patients will take approximately 2
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine maximum tolerated dose (MTD) of ECI301 delivered in combination with 30 Gy external beam radiation to patients with metastatic or locally advanced cancer.
William D Figg, Pharm.D.
National Cancer Institute (NCI)
United States: Federal Government
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