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

Completed · Phase 1

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00860522

Run by

Milton S. Hershey Medical Center

People needed

11

Starts

2009-03-01

Expected to finish

2017-02-20

Last updated by the study team

2019-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penn State Hershey Cancer Institute — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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