- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02845414
Study of CD133KDEL Toxin in the Treatment for Solid Tumors
Phase I Study Of Stem-Cell Directed Deimmunized CD133KDEL Toxin In The Treatment Of Solid Tumors
Study Overview
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center at University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intravenous Infusion of dCD133KDEL
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: Day 28
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Maximum tolerated dose (MTD)
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Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicity (DLT)
Time Frame: 21 days after the first dose of dCD133KDEL
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A ≥ grade 3 (CTCAE v4.0) adverse event within 21 days after the first dose of dCD133KDEL and at least possibility attributable to dCD133KDEL
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21 days after the first dose of dCD133KDEL
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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
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Tumor response will be evaluated and summarized by dose level in a contingency table with its 95% confidence interval
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Disease assessment between days 29, 30, 31, 32, 33. Follow up for disease response every weeks 6, 7 ,8 ,9, 10,11,12
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016LS026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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