Status:
COMPLETED
JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 dos...
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00860522
Start Date
March 1 2009
End Date
February 20 2017
Last Update
April 5 2019
Active Locations (1)
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1
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033