- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00860522
JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
April 3, 2019 updated by: David F. Claxton, MD, Milton S. Hershey Medical Center
A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
This is a Phase 1, open-label, dose escalation study of JVRS-100.
The study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose.
In stage 1, an accelerated titration schema will be followed with one patient at each dose level.
Stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached.
Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined.
The cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose.
Study Overview
Detailed Description
This is a Phase 1, open-label, dose escalation study of JVRS-100.
The study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose.
In stage 1, cohorts of three will be treated at each dose level however doses will be doubled from level to level.
Stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached.
Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined.
The cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose.
The Principal Investigator will assign dose level to be administered to all patients.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age
- Histologically or cytologically documented relapsed or refractory acute leukemia
- Unlikely to benefit from standard therapy in the opinion of the investigator or refuse standard therapy
- ECOG performance status 0-2
- Adequate renal and hepatic function
- No hematologic criteria for WBC, Hbg or platelets
- Negative virology screen for HIV, hepatitis B surface antigen & hepatitis C
- Female patients of childbearing potential must have a negative serum pregnancy test
- Male & female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months afte the last dose of study treatment.
- Patients post blood or marrow transplant should demonstrate a circulating CD8 count of at lest 200 cells/ul
Exclusion Criteria:
- Active CNS leukemia
- Current concomitant chemotherapy, radiation therapy or immunotherapy
- Receipt of any investigational agent within 28 days of first dose of JVRS-100
- Persistent clinically significant toxicity from prior anticancer therapy that is > Grade 2 (NCI CTCAE v3.0)
- Bone marrow or stem cell transplant within 3 months prior to first dose of JVRS-100
- Chronic administration of immunosuppressive agents within 14 days of first dose of JVRS-100. Use of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas is allowed.
- Pregnant or lactating
- History of prior malignancy other than leukemia within the past 5 years, excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled
- Any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase I
Three patients will be enrolled at dose Level 1.
If the patient does not completed the three infusion of JVRS-100 during cycle 1 for reason other than toxicity, another patient will be accrued at the same dose level.
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Level 1: 0.5 µg/Kg D1,8,15; Level 2: 1.0 µg/Kg D1,8,15; Level 3:2.0 µg/Kg 1,15; Level 4: 2.0 µg/Kg D1,8,15; Level 5: 4.0 µg/Kg D1,15
Other Names:
Change to Stage 2 with starting dose of 4.0 µg/Kg D1,8,15 if no toxicity level by Level 5.
Other Names:
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Experimental: Phase II
3 patients will be enrolled at a given dose level.
If one of these patients experiences a dose limiting toxicity, an additional 3 patients will be enrolled at the given dose level.
If the 1st 2 subjects enrolled and treated at a given dose experience dose limiting toxicities, no additional subjects will be enrolled at that dose.
Dose escalation may proceed if < 2/6 patients at a given dose level experience a LDT.
If ≥ 2/6 patients experience a DLT at a given dose level, the next lower dose level will be considered the RP2D.
If a patient does not complete the 3 infusions of JVRS-100 during Cycle 1 for reasons other than toxicity, another patient will be accrued at the same dose level.
Once the RP2D is established, the cohort will be expanded to a total of 12 patients.
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Level 1: 0.5 µg/Kg D1,8,15; Level 2: 1.0 µg/Kg D1,8,15; Level 3:2.0 µg/Kg 1,15; Level 4: 2.0 µg/Kg D1,8,15; Level 5: 4.0 µg/Kg D1,15
Other Names:
Change to Stage 2 with starting dose of 4.0 µg/Kg D1,8,15 if no toxicity level by Level 5.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability of JVRS-100
Time Frame: Day 30 of cycle #1
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Toxicities will be assessed on day 30 of cycle 1.
Establish dose limiting toxicity and a maximum tolerated dose recommended Phase 2 dose.
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Day 30 of cycle #1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Define parameters of immune activation after JVRS-100 therapy.
Time Frame: Day 30 of cycle #1
|
Activation of peripheral blood cells including T-cell subsets, CD4+ and CD8+ cells, B-cells, and NK cells will be studied for activation markers including cell surface phenotypic changes, and expression of intracellular cytokines.
Changes in circulating cytokine concentrations will be studied, as will functional properties of circulating immune effector and activating cells.
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Day 30 of cycle #1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David F Claxton, MD, Milton S. Hershey Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2009
Primary Completion (Actual)
October 31, 2014
Study Completion (Actual)
February 20, 2017
Study Registration Dates
First Submitted
March 11, 2009
First Submitted That Met QC Criteria
March 11, 2009
First Posted (Estimate)
March 12, 2009
Study Record Updates
Last Update Posted (Actual)
April 5, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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