ECI301 and Radiation for Advanced or Metastatic Cancer

NCT01441115 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 11024811-C-0248
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Neoplasm Metastasis; Radiation Oncology; Neoplasm; Metastasis

Keywords

Metastasis; Cancer; Radiation Therapy; Locally Advanced; Palliation; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer

  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.

  During treatment or the first three weeks after treatment

Secondary Outcomes (4)

• 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

• 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

Other Outcomes (2)

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

  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.

• Number of Participants With a Dose-Limiting Toxicity (DLT)

  During treatment or the first three weeks after treatment

Study Arms (1)

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

EXPERIMENTAL

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

Procedure: Radiation Therapy; Drug: ECI301

Interventions

Radiation Therapy PROCEDURE

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

ECI301 DRUG

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Life expectancy of greater than 3 months
• Histologically confirmed cancer
• Extracranial metastatic cancer or locally advanced cancer for which palliative radiotherapeutic management would be appropriate (no more than two sites will be treated on this trial)
• Patients must have measurable or evaluable disease at the site(s) requiring radiation
• Adequate marrow and organ function defined as
• absolute neutrophil count (ANC) \> 1.5 times 10(9)/L,
• platelet count \> 100 times 10(9),
• hemoglobin \>9 g/L.
• creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal
• serum bilirubin \<1.5 times upper limit reference range (ULRR),
• alanine aminotransferase (ALT), aspartate aminotransferase (AST), or
• alkaline phosphatase (ALP) \<2.5 times the ULRR (\<5 times the ULRR in the presence
• of liver metastases)

You may not qualify if:

• Pregnant or lactating females
• Contraindications to radiotherapy (i.e. prior radiotherapy to the intended treatment site)
• Untreated or previously treated but progressive intracranial metastases (Patients with previously treated intracranial metastases should have no clinical evidence of progression and be at least 4 weeks from therapy for intracranial metastases)
• Need for emergent radiotherapy (defined as need for radiotherapy within 24 hours of consultation at the judgment of the treating radiation oncologist)
• Active treatment with immunosuppressive therapy and subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism
• Chemotherapy, radiation therapy, Tamoxifen or investigational therapy during the 4 weeks prior to initiation of protocol therapy
• History of rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, temporal arteritis or any other autoimmune disease
• History of organ transplant
• Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C positivity
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Use of excluded immune modulating medications within 4 weeks prior to protocol therapy, or requirement for concurrent use.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Friedman EJ. Immune modulation by ionizing radiation and its implications for cancer immunotherapy. Curr Pharm Des. 2002;8(19):1765-80. doi: 10.2174/1381612023394089.

  PMID: 12171547 BACKGROUND

• Sharp HJ, Wansley EK, Garnett CT, Chakraborty M, Camphausen K, Schlom J, Hodge JW. Synergistic antitumor activity of immune strategies combined with radiation. Front Biosci. 2007 Sep 1;12:4900-10. doi: 10.2741/2436.

  PMID: 17569618 BACKGROUND

• Maurer M, von Stebut E. Macrophage inflammatory protein-1. Int J Biochem Cell Biol. 2004 Oct;36(10):1882-6. doi: 10.1016/j.biocel.2003.10.019.

  PMID: 15203102 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Deborah E. Citrin
• Organization: National Cancer Institute

citrind@mail.nih.gov

301-496-5457

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2011
• First Posted: September 27, 2011
• Study Start: September 6, 2011
• Primary Completion: April 24, 2013
• Study Completion: April 24, 2013
• Last Updated: December 28, 2021
• Results First Posted: December 28, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)