Phase I Trial of ECI301 in Combination With Radiation in Patients With Advanced or Metastatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Study Overview
Brief Summary
Background:
- 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).
Objectives:
- To test ECI301 with radiation therapy for advanced or metastatic cancer.
Eligibility:
- People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy.
Design:
- 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.
- Follow-up visits will include blood tests and imaging studies.
Detailed Description
Background:
- 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 alpha, a 70 amino acid chemokine that is a ligand for C-C chemokine receptor type 1 (CCR1) and C-C chemokine receptor type 5 (CCR5), the chemokine receptors of immature dendritic cells.
- ECI301 has been shown to enhance the effect of radiotherapy in animal models.
Objectives:
-
The primary objective is to determine the maximum tolerated dose (MTD) of ECI301 delivered in combination with 30 Gray (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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
Intervention: Radiation Therapy (Procedure)
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
Intervention: ECI301 (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Time Frame: During treatment or the first three weeks after treatment
MTD is defined as the highest dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) during treatment or the first three weeks after treatment, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. Examples of DLT is any grade 3 or greater non-hematologic toxicity, ang grade 3 neutropenia or thrombocytopenia, any grade 4 anemia, and toxicity requiring a cumulative radiation treatment delay of 4 or more days.
Secondary Outcomes
- Pharmacologic Parameters Following the Intravenous Dose of ECI301(Following the intravenous dose of ECI301)
- Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301(6 months)
- Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer(Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.)
- Humoral and Cellular Immune Responses(Before and after completion of ECI301)
Investigators
Deborah Citrin, M.D.
Principal Investigator
National Cancer Institute (NCI)