A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
18 Years
N/A
Both
Leukemia
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:
Interventional
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:
Yes
Principal Investigator
David F Claxton, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Milton S. Hershey Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
08-031
NCT ID:
NCT00860522
Start Date:
March 2009
Completion Date:
October 2013
Related Keywords:
- Leukemia
- relapsed leukemia
- refractory leukemia
- Leukemia
Name | Location |
|---|---|
| Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |
