Metastatic Non-Small Cell Lung CancerI-CRESTNCT01936961
Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors
A study testing CTLA-4 Antibody and Hypofractionated Radiotherapy in people with Metastatic Non-Small Cell Lung Cancer and Metastatic Colon Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for complete response in solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer, Metastatic Colon Cancer, Metastatic Triple Negative Breast Cancer
- What is being tested?
- CTLA-4 Antibody and Hypofractionated Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has definitive histologically or cytologically confirmed metastatic NSCLC, colon, or TNB cancer.
- Patient has one or more metastatic tumors measurable by CT scan (or PET/CT, if patient is allergic to CT contrast media).
- For NSCLC patients without EGFR or ALK abnormalities amenable to EGFR or ALK targeted therapy: patients must have received no more than at least 2 or 3 cycles of either first- or second-line systemic therapy for the treatment of metastatic disease. For NSCLC patients with EGFR or ALK abnormalities amenable to receive EGFR or ALK targeted therapy: patients must have progressed on first-line EGFR or ALK targeted therapy and received no more than at least 2 or 3 cycles of either second- or third-line systemic therapy for the treatment of metastatic disease.
- For colon cancer patients: patients must have patients must have received no more than at least 2 or 3 cycles of either first- or second-line systemic therapy for the treatment of metastatic disease.
- For TNB cancer patients, patients must have patients must have received no more than at least 2 or 3 cycles of either first- or second-line systemic therapy for the treatment of metastatic disease.
- At the time of screening, all patients must have scans (within 28 days) showing stable disease by RECIST 1.1. Where applicable, measurable tumor marker (e.g. CA19-9, CEA, or CA125) collected within 14 days must be at least 10% less than baseline value on most recent systemic therapy (baseline value has to be abnormal elevated).
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- Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening:
- Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 9 g/dL.
- Serum creatinine ≤2.0, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
- Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the upper limit of normal range, then a free T4 within institutional normal limits is acceptable.
- Persistent prior systemic therapy non-hematologic AE grade ≥2 (except alopecia or correctable electrolyte abnormality with supplementation)
- Patient has a Karnofsky performance status (KPS) ≥ 70.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
Who cannot join
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
- Requiring daily corticosteroid dose ≥ 7.5 mg prednisone or equivalent per day.
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- Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindication or Special Warnings and Precautions sections of the product or comparator SmPC or Prescribing Information.
- Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Patient will be receiving any other anti-cancer therapy during participation in this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Regional Medical Center
Goodyear, Arizona, 85338
About this study
Official title: A Pilot Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors (I-CREST)
The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for complete response in solid tumors
- Conditions
- Metastatic Non-Small Cell Lung Cancer, Metastatic Colon Cancer, Metastatic Triple Negative Breast Cancer
- Being tested
- CTLA-4 Antibody, Hypofractionated Radiotherapy
- Keywords
- Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Triple Negative Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTLA-4 AntibodyDrug
administered intravenously over 90 minutes every 3 weeks for a total of four doses
Hypofractionated RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| CTLA-4 Antibody + hypofractionated radiotherapy | Experimental | Hypofractionated radiotherapy completed at least 3 days prior to receipt of CTLA-4 Antibody Receives: Drug: CTLA-4 Antibody; Radiation: Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Complete response by immune-related response criteria (irRC)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glen J Weiss, MD, Principal investigator, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936961
- Sponsor's protocol ID
- 13-03
- Acronym
- I-CREST
- Status last verified
- Dec 2015
- First submitted
- 3 Sep 2013
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors (I-CREST)
- ClinicalTrials.gov ID
- NCT01936961
- Acronym / sponsor ID
- I-CREST / 13-03
- Conditions
- Metastatic Non-Small Cell Lung Cancer, Metastatic Colon Cancer, Metastatic Triple Negative Breast Cancer
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for complete response in solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTLA-4 Antibody + hypofractionated radiotherapy | Experimental | Drug: CTLA-4 Antibody, Radiation: Hypofractionated RadiotherapyHypofractionated radiotherapy completed at least 3 days prior to receipt of CTLA-4 Antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient has definitive histologically or cytologically confirmed metastatic NSCLC, colon, or TNB cancer.
- Patient has one or more metastatic tumors measurable by CT scan (or PET/CT, if patient is allergic to CT contrast media).
- For NSCLC patients without EGFR or ALK abnormalities amenable to EGFR or ALK targeted therapy: patients must have received no more than at least 2 or 3 cycles of either first- or second-line systemic therapy for the treatment of metastatic disease. For NSCLC patients with EGFR or ALK abnormalities amenable to receive EGFR or ALK targeted therapy: patients must have progressed on first-line EGFR or ALK targeted therapy and received no more than at least 2 or 3 cycles of either second- or third-line systemic therapy for the treatment of metastatic disease.
- For colon cancer patients: patients must have patients must have received no more than at least 2 or 3 cycles of either first- or second-line systemic therapy for the treatment of metastatic disease.
- For TNB cancer patients, patients must have patients must have received no more than at least 2 or 3 cycles of either first- or second-line systemic therapy for the treatment of metastatic disease.
Key exclusion criteria (10 listed)
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTLA-4 Antibodyadministered intravenously over 90 minutes every 3 weeks for a total of four doses | Drug | CTLA-4 Antibody + hypofractionated radiotherapy |
| Hypofractionated Radiotherapy | Radiation | CTLA-4 Antibody + hypofractionated radiotherapy |
Primary outcome
Complete Response
Time frame: One year
Complete response by immune-related response criteria (irRC)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen J Weiss, MD principal investigator
Western Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTLA-4 Antibody and Hypofractionated Radiotherapy in people with Metastatic Non-Small Cell Lung Cancer and Metastatic Colon Cancer, run by Western Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.