NCT01441115

ECI301 and Radiation for Advanced or Metastatic Cancer

Terminated Phase 1 Results posted Last updated 28 December 2021

What this trial tests

Phase 1 trial testing Radiation Therapy in Cancer in 2 participants. Terminated before completion.

Timeline

6 September 2011

Primary endpoint
24 April 2013

24 April 2013

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	6 September 2011
Primary completion	24 April 2013
Estimated completion	24 April 2013
Sites	1 location across United States

Drugs / interventions tested

• Radiation Therapy — full drug profile →
• ECI301 — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
• Radiation Oncology — all drugs for Radiation Oncology →
• Neoplasm — all drugs for Neoplasm →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Cancer or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Secondary · 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.

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and the Radiation Therapy Oncology Group (RTOG) criteria.

Alanine aminotransferase increased

Group	Value	95% CI
Unrelated	0
Unlikely Related	1
Possibly Related	0

Anemia

Group	Value	95% CI
Unrelated	4
Unlikely Related	0
Possibly Related	0

Aspartate aminotransferase increased

Group	Value	95% CI
Unrelated	0
Unlikely Related	1
Possibly Related	0

Edema limbs

Group	Value	95% CI
Unrelated	1
Unlikely Related	0
Possibly Related	0

Erythema multiforme

Group	Value	95% CI
Unrelated	0
Unlikely Related	0
Possibly Related	1

Gastritis

Group	Value	95% CI
Unrelated	0
Unlikely Related	1
Possibly Related	0

Headache

Group	Value	95% CI
Unrelated	1
Unlikely Related	0
Possibly Related	0

Hyperkalemia

Group	Value	95% CI
Unrelated	0
Unlikely Related	1
Possibly Related	0

Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301 Secondary · 6 months

Response will be measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qu

Complete Response

Group	Value	95% CI
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	0

Partial Response

Group	Value	95% CI
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	0

Stable Disease

Group	Value	95% CI
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	1

Progressive Disease

Group	Value	95% CI
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	0

Here is the Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) Secondary · 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.

Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the prev

Group	Value	95% CI
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	1

Number of Participants With a Dose-Limiting Toxicity (DLT) Secondary · During treatment or the first three weeks after treatment

Examples of DLT is any grade 3 or greater non-hematologic toxicity, any grade 3 neutropenia or thrombocytopenia, any grade 4 anemia; nausea, vomiting, diarrhea, tumor pain, or pre-existing hyponatremia, dyselectrolytemia, or orthostatic hypotension that has been optimally treated with anti-emetics, anti-diarrheal, analgesics, or hydration and which persists for over 48 hours despite maximal medical therapy, and toxicity requiring a cumulative radiation treatment delay of 4 or more days.

Group	Value	95% CI
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (11 terms — click to expand)

Reaction	System	ECI301 Dose Level 1 - 25 u…
Alanine aminotransferase increased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
Aspartate aminotransferase increased	Investigations	—
Edema limbs	General disorders	—
Erythema multiforme	Skin and subcutaneous tissue disorders	—
Gastritis	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Hyperkalemia	Metabolism and nutrition disorders	—
Lymphocyte count decreased	Investigations	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Urinary tract infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT01441115 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. CCL3 augments tumor rejection and enhances CD8⁺ T cell infiltration through NK and CD103⁺ dendritic cell recruitment via IFNγ.
   Allen F, Bobanga ID, Rauhe P, Barkauskas D, et al · · 2018 · cited 124× · PMID 29399390 · DOI 10.1080/2162402x.2017.1393598
2. Reduced Number of Lymphocytes by X-ray Irradiation: A Problem in a Combination Therapy Trial that Elicits the Abscopal Effect in Preclinical Studies Using Electron Beam Irradiation.
   Kanegasaki S, Yamashita T, Tsuchiya T. · · 2019 · cited 3× · PMID 31058025 · DOI 10.7759/cureus.4142