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AMP-224, a PD-1 Inhibitor, With Stereotactic Body Radiation Therapy in Metastatic Colorectal Cancer

NCT02298946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-02-22

Study results available
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Summary

Background:

\- T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in people with cancer. They think the drug might work even better when combined with a certain type of radiation therapy.

Objective:

\- To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic body radiation therapy (SBRT) directed to the liver.

Eligibility:

\- People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to the liver and not be responding to treatment.

Design:

* Participants will be screened with a medical history, physical exam, and blood and urine tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an electrocardiogram (ECG) heart test.
* Participants will have a small part of their tumor removed by needle (biopsy).
* Participants will have 8 study visits over about 10 weeks.
* At 1 visit, they will have another tumor biopsy.
* At 1 visit, they will get a chemotherapy drug through a vein (intravenous (IV)).
* At 6 visits, they will receive AMP-224 through an IV.
* At 1 or 3 visits, they will have SBRT. Computed tomography (CT) scans will map the position of their tumor. Radiation beams of different intensities at different angles will be directed to the tumor.
* At all visits, some screening procedures may be repeated.
* After treatment ends, participants will have 7 follow-up visits over about 5 months. Blood will be drawn. Some screening procedures may be repeated.

Conditions

Interventions

DRUG

AMP-224

10mg/kg on day 1 then every 14 days for a total of 6 doses.

RADIATION

Stereotactic Body Radiation Therapy(SBRT)

Dose Level 1: 8Gy x 1 day. Dose Level 2: 8Gy x 3 days

DRUG

Cyclophosphamide

200mg/m(2) IV on day 0.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tim F Greten, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-11-21
Primary Completion
2016-07-13
Completion
2017-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02298946 on ClinicalTrials.gov