Clinical trial NCT00860522: JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
Official title: A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Keywords: relapsed leukemia
refractory leukemia
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Tolerability of JVRS-100
timeFrame: Day 30 of cycle #1
Secondary outcomes:
measure: Define parameters of immune activation after JVRS-100 therapy.
timeFrame: Day 30 of cycle #1
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: David F Claxton, MD
role: PRINCIPAL_INVESTIGATOR
References: