A Phase 1 interventional study of Radiation Therapy and ECI301 in Cancer, Neoplasm Metastasis and Radiation Oncology, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-12-28.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
Background:
Objectives:
The secondary objectives are:
To evaluate the humoral and cellular immune responses by:
Eligibility:
Design:
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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2.1.1.1 Age greater than or equal to18 years.
2.1.1.2 Eastern Cooperative Oncology Group (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
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 childbearing 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, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, temporal arteritis or any other autoimmune disease
2.1.2.8 History of organ transplant
2.1.2.9 Human immunodeficiency virus (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.
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
Procedure: Radiation Therapy · Drug: ECI301
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.
Time frame: During treatment or the first three weeks after treatment
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
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and the Radiation Therapy Oncology Group (RTOG) criteria.
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.
Humoral and Cellular Immune Responses
Measurement of circulating precursor dendritic cells, circulating macrophage inflammatory protein-1 alpha (MIP-α), and assessment of T-lymphocytes will be measured by flow cytometry and assays for type II interferon (IFNγ) production.
Time frame: Before and after completion of ECI301
Pharmacologic Parameters Following the Intravenous Dose of ECI301
Pharmacologic parameters will be derived using non-compartmental analysis.
Time frame: Following the intravenous dose of ECI301
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
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 qualify for progressive disease.
Time frame: 6 months
Here is the Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
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 previous outcomes mentioned.
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.
Number of Participants With a Dose-Limiting Toxicity (DLT)
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.
Time frame: During treatment or the first three weeks after treatment
| Milestone | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Started | 2 |
| Completed | 1 |
| Not completed | 1 |
| Withdrew: Taken off study - principal investigator discretion | 1 |
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.
No measurements were reported for this outcome.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and the Radiation Therapy Oncology Group (RTOG) criteria.
| Adverse events | Unrelated | Unlikely Related | Possibly Related |
|---|---|---|---|
| Alanine aminotransferase increased | 0 | 1 | 0 |
| Anemia | 4 | 0 | 0 |
| Aspartate aminotransferase increased | 0 | 1 | 0 |
| Edema limbs | 1 | 0 | 0 |
| Erythema multiforme | 0 | 0 | 1 |
| Gastritis | 0 | 1 | 0 |
| Headache | 1 | 0 | 0 |
| Hyperkalemia | 0 | 1 | 0 |
| Lymphocyte count decreased | 1 | 0 | 0 |
| Pain in extremity | 1 | 0 | 0 |
| Urinary tract infection | 0 | 0 | 1 |
Measurement of circulating precursor dendritic cells, circulating macrophage inflammatory protein-1 alpha (MIP-α), and assessment of T-lymphocytes will be measured by flow cytometry and assays for type II interferon (IFNγ) production.
No measurements were reported for this outcome.
Pharmacologic parameters will be derived using non-compartmental analysis.
No measurements were reported for this outcome.
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 qualify for progressive disease.
| Participants | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Complete Response | 0 |
| Partial Response | 0 |
| Stable Disease | 1 |
| Progressive Disease | 0 |
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 previous outcomes mentioned.
| Participants | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Here is the Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 1 |
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.
| Participants | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Number of Participants With a Dose-Limiting Toxicity (DLT) | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Alanine aminotransferase increasedInvestigations | 1/1 |
| AnemiaBlood and lymphatic system disorders | 1/1 |
| Aspartate aminotransferase increasedInvestigations | 1/1 |
| Edema limbsGeneral disorders | 1/1 |
| Erythema multiformeSkin and subcutaneous tissue disorders | 1/1 |
| GastritisGastrointestinal disorders | 1/1 |
| HeadacheNervous system disorders | 1/1 |
| HyperkalemiaMetabolism and nutrition disorders | 1/1 |
| Lymphocyte count decreasedInvestigations | 1/1 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/1 |
| Age, Categorical(Participants) | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 1 |
| Age, Continuous(years) | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Mean | 60.1 ± 9.62 |
| Sex: Female, Male(Participants) | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Female | 2 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer |
|---|---|
| United States | 2 |
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