ECI301 and Radiation for Advanced or Metastatic Cancer

• Status: Terminated
• Trial end date: 2013-04-24
• Target enrollment: 0
• Participant gender: All

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.

• Followup visits will include blood tests and imaging studies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

• INCLUSION CRITERIA:

2.1.1.1 Age greater than or equal to18 years.

2.1.1.2 ECOG performance status less than or equal to 2.

2.1.1.3 Life expectancy of greater than 3 months

2.1.1.4 Histologically confirmed cancer

2.1.1.5 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)

2.1.1.6 Patients must have measurable or evaluable disease at the site(s) requiring radiation

2.1.1.7 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)

2.1.1.8 Female patients of child bearing potential must either be surgically sterile to prevent pregnancy, be at least 1-year post-menopausal, or have had no menses for 12 months, or agree to use reliable methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, copper banded intrauterine device, tubal ligation or abstinence) from time of screening until 4 weeks after discontinuing study treatment. It is not known whether ECI301 has the capacity to induce hepatic enzymes so hormonal contraceptives should be combined with a barrier method of contraception.

2.1.1.9 Male patients must agree to use barrier contraception (i.e. condoms) and refrain from donating sperm from the start of dosing until 16 weeks after discontinuing study treatment. If male patients wish to father children they should be advised to arrange for freezing of sperm prior to the start of study treatment.

EXCLUSION CRITERIA:

2.1.2.1 Pregnant or lactating females

2.1.2.2 Contraindications to radiotherapy (i.e. prior radiotherapy to the intended treatment site)

2.1.2.3 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)

2.1.2.4 Need for emergent radiotherapy (defined as need for radiotherapy within 24 hours of consultation at the judgment of the treating radiation oncologist)

2.1.2.5 Active treatment with immunosuppressive therapy and subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism

2.1.2.6 Chemotherapy, radiation therapy, Tamoxifen or investigational therapy during the 4 weeks prior to initiation of protocol therapy

2.1.2.7 History of rheumatoid arthritis, systemic lupus erythematosus, Sj(SqrRoot)(Delta)grens disease, sarcoidosis, vasculitis, polymyositis, temporal arteritis or any other autoimmune disease

2.1.2.8 History of organ transplant

2.1.2.9 HIV, Hepatitis B, or Hepatitis C positivity

2.1.2.10 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

2.1.2.11 Use of excluded immune modulating medications within 4 weeks prior to protocol therapy, or requirement for concurrent use.