JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia

• Status: Completed
• Trial end date: 2017-02-20
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center

Criteria

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