Solid TumorsPhase 1NCT02845414
Study of CD133KDEL Toxin in the Treatment for Solid Tumors
A Phase 1 study testing CD133KDEL (dCD133KDEL) in people with Solid Tumors, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a single center, phase I dose escalation study designed to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of deimmunized CD133KDEL (dCD133KDEL), a ligand-directed, deimmunized pseudomonas toxin against CD133, in patients with advanced, previously treated, refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- CD133KDEL (dCD133KDEL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2018to Jan 2022
- Phase
- Phase 1
- 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
- Pathologically or cytologically confirmed, metastatic or unresectable solid tumor malignancy.
- Measurable or evaluable disease per RECIST 1.1 criteria (Appendix II), or modified RECIST criteria for mesothelioma (Appendix II).
- At least 1 prior line of systemic therapy considered standard for the malignancy, and for which no standard therapies exist. Prior systemic chemotherapy, immunotherapy, biological therapy, radiation therapy and/or surgery are allowed before the first dose of dCD133KDEL with the following restrictions:
- At least 14 days since any systemic therapy.
- At least 28 days since any experimental therapy.
- At least 14 days since any radiation therapy.
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- At least 28 days since any major surgery, defined as a surgery involving a risk to the life of the patient, specifically, an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity.
- Recovered from the acute toxic effects (≤ grade 1, CTCAE v4.0) of previous cancer treatment prior to study registration.
- ECOG performance status 0 or 1 (Appendix III).
- Adequate organ function within 14 days of study registration, defined as follows System Parameter Laboratory Value Hematologic Absolute neutrophil count (ANC) ≥1.5 x 10^9 /L Hemoglobin* 9 g/dL Platelets* ≥100 x 10^9 /L Hepatic Total bilirubin < 2 x ULN^ ALT < 2 x ULN^ Renal Serum creatinine < 1.5 mg/dL OR estimated GFR >50 by modified Cockcroft-Gault (* Patient may not have had a transfusion within 7 days
- ^ Upper limit of institutional normal.)
- Albumin ≥ 3.0 gm/dL within 14 days of study registration.
- Adequate cardiac function, defined as an ejection fraction ≥40% on transthoracic echocardiogram done within 14 days of study registration.
- QT/QTc interval ≤ 450 milliseconds within 14 days of study registration. If this screening EKG demonstrates a QT/QTc interval > 450 milliseconds, a second screening EKG will be done within 7 days to document that the QT prolongation is persistent. The patient will be eligible if the second screening EKG shows a QT/QTc interval ≤ 450 milliseconds but will require additional EKGs during the study period as outlined in section 6.1.2.
- Adequate pulmonary function, defined as resting oxygen saturation ≥ 90% on room air and/or pulmonary function tests (PFT) showing corrected DLCO >50% and FEV1 ≥ 2 liters or ≥ 60% of predicted. PFT testing is required within 28 days of study registration only if the patient is symptomatic or prior known impairment is present.
- Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraception methods, one of which must be a barrier method, during the study and for ≥12 weeks after the last dose of dCD133KDEL. Effective methods include intrauterine device (IUD), Depo-Provera injection or implant, Evra patch, NuvaRing, oral contraception, and diaphragm/spermicide with condom.
- Ability to understand and provide voluntary written consent.
Who cannot join
- Known active CNS metastases or neurological symptoms possibly related to CNS metastases, spinal cord compression, or evidence of leptomeningeal disease. Patients with a history of brain metastases who have undergone whole brain radiation or gamma knife treatment ≥ 28 days prior to registration, whose metastases are documented as stable or resolved at the time of screening by brain MRI (or head CT with contrast for those who are intolerant of MRI), and do not require ≥10 mg of prednisone equivalent for symptom management related to the brain metastases, are eligible.
- Known uncontrolled cardiac arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities within 28 days of registration.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- History of any one or more cardiovascular conditions within 12 weeks of study registration
- cardiac angioplasty or stenting
- myocardial infarction
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- unstable angina
- coronary artery bypass graft surgery
- symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA, Appendix IV)
- transient ischemic attack and/or cerebrovascular accident
- History of another malignancy other than non-melanoma skin cancer or treated carcinoma in situ, unless documented to be disease free for at least 3 years.
- History of allergic reaction or sensitivity to compounds of similar chemical or biological composition to dCD133KDEL, or any of the components of dCD133KDEL (i.e. Polysorbate 80).
- Pregnant or breastfeeding women, or women intending to become pregnant. Females of child bearing potential must have a negative serum pregnancy test within 14 days of study registration.
- Prior toxin-directed therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Study Of Stem-Cell Directed Deimmunized CD133KDEL Toxin In The Treatment Of Solid Tumors
This is a single center, phase I dose escalation study designed to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of deimmunized CD133KDEL (dCD133KDEL), a ligand-directed, deimmunized pseudomonas toxin against CD133, in patients with advanced, previously treated, refractory solid tumors.
- Conditions
- Solid Tumors
- Being tested
- CD133KDEL (dCD133KDEL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD133KDEL (dCD133KDEL)Drug
Patients will receive dCD133KDEL at the assigned dose level via a 30-minute intravenous infusion on days 1, 3, 5, 8, 10 and 12 (total of 6 doses) of a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Infusion of dCD133KDEL | Experimental | Not described Receives: Drug: CD133KDEL (dCD133KDEL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD)
Measured: Day 28
Secondary outcomes (2)
Dose Limiting Toxicity (DLT)
A ≥ grade 3 (CTCAE v4.0) adverse event within 21 days after the first dose of dCD133KDEL and at least possibility attributable to dCD133KDEL
Measured: 21 days after the first dose of dCD133KDEL
Tumor response defined as partial and complete response according to RECIST 1.1 criteria, with its 95% confidence interval
Tumor response will be evaluated and summarized by dose level in a contingency table with its 95% confidence interval
Measured: Disease assessment between days 29, 30, 31, 32, 33. Follow up for disease response every weeks 6, 7 ,8 ,9, 10,11,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Fujioka, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845414
- Sponsor's protocol ID
- 2016LS026
- Status last verified
- Oct 2018
- First submitted
- 18 Jul 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of Stem-Cell Directed Deimmunized CD133KDEL Toxin In The Treatment Of Solid Tumors
- ClinicalTrials.gov ID
- NCT02845414
- Acronym / sponsor ID
- 2016LS026
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 27 Jul 2016 (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.
This is a single center, phase I dose escalation study designed to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of deimmunized CD133KDEL (dCD133KDEL), a ligand-directed, deimmunized pseudomonas toxin against CD133, in patients with advanced, previously treated, refractory 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 |
|---|---|---|
| Intravenous Infusion of dCD133KDEL | Experimental | Drug: CD133KDEL (dCD133KDEL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Pathologically or cytologically confirmed, metastatic or unresectable solid tumor malignancy.
- Measurable or evaluable disease per RECIST 1.1 criteria (Appendix II), or modified RECIST criteria for mesothelioma (Appendix II).
- At least 1 prior line of systemic therapy considered standard for the malignancy, and for which no standard therapies exist. Prior systemic chemotherapy, immunotherapy, biological therapy, radiation therapy and/or surgery are allowed before the first dose of dCD133KDEL with the following restrictions:
- Recovered from the acute toxic effects (≤ grade 1, CTCAE v4.0) of previous cancer treatment prior to study registration.
- ECOG performance status 0 or 1 (Appendix III).
Key exclusion criteria (15 listed)
- Known active CNS metastases or neurological symptoms possibly related to CNS metastases, spinal cord compression, or evidence of leptomeningeal disease. Patients with a history of brain metastases who have undergone whole brain radiation or gamma knife treatment ≥ 28 days prior to registration, whose metastases are documented as stable or resolved at the time of screening by brain MRI (or head CT with contrast for those who are intolerant of MRI), and do not require ≥10 mg of prednisone equivalent for symptom management related to the brain metastases, are eligible.
- Known uncontrolled cardiac arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities within 28 days of registration.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- History of any one or more cardiovascular conditions within 12 weeks of study registration
- History of another malignancy other than non-melanoma skin cancer or treated carcinoma in situ, unless documented to be disease free for at least 3 years.
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 |
|---|---|---|
| CD133KDEL (dCD133KDEL)Patients will receive dCD133KDEL at the assigned dose level via a 30-minute intravenous infusion on days 1, 3, 5, 8, 10 and 12 (total of 6 doses) of a 28-day cycle. | Drug | Intravenous Infusion of dCD133KDEL |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Day 28
Maximum tolerated dose (MTD)
2 secondary outcomes
Dose Limiting Toxicity (DLT)
Time frame: 21 days after the first dose of dCD133KDEL
Tumor response defined as partial and complete response according to RECIST 1.1 criteria, with its 95% confidence interval
Time frame: Disease assessment between days 29, 30, 31, 32, 33. Follow up for disease response every weeks 6, 7 ,8 ,9, 10,11,12
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 3 Oct 2018.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
Naomi Fujioka, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD133KDEL (dCD133KDEL) in people with Solid Tumors, run by Masonic Cancer Center, University of Minnesota 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 17 inclusion and 15 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 3 Oct 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum tolerated dose (MTD) (time frame: Day 28). 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 3 Oct 2018.