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ECI301 and Radiation for Advanced or Metastatic Cancer

NCT01441115 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-12-28

Study results available
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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.

Conditions

Interventions

PROCEDURE

Radiation Therapy

DRUG

ECI301

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Deborah E Citrin, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-06
Primary Completion
2013-04-24
Completion
2013-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441115 on ClinicalTrials.gov