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A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia

Phase 1
18 Years
Open (Enrolling)

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Trial Information

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, 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability of JVRS-100

Outcome Description:

Toxicities will be assessed on day 30 of cycle 1. Establish dose limiting toxicity and a maximum tolerated dose recommended Phase 2 dose.

Outcome Time Frame:

Day 30 of cycle #1

Safety Issue:


Principal Investigator

David F Claxton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

October 2013

Related Keywords:

  • Leukemia
  • relapsed leukemia
  • refractory leukemia
  • Leukemia



Penn State Hershey Cancer Institute Hershey, Pennsylvania  17033