ECI301 and Radiation for Advanced or Metastatic Cancer
- ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic).
- To test ECI301 with radiation therapy for advanced or metastatic cancer.
- People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy.
- Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies.
- All participants will have radiation therapy 5 days a week for 2 weeks.
- They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment.
- After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation.
- Followup visits will include blood tests and imaging studies....
Procedure: Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of ECI301 in Combination With Radiation in Patients With Advanced or Metastatic Cancer|
- Determine maximum tolerated dose (MTD) of ECI301 delivered in combination with 30 Gy external beam radiation to patients with metastatic or locally advanced cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determine safety & tolerability of ECI301 in combination with radiation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Evaluate the humoral and cellular immune responses. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Define pharmacologic parameters [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Describe the response at the radiated site and distant. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
- 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 cells.
- 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 cancer
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 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441115
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Deborah E Citrin, M.D.||National Cancer Institute (NCI)|