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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860522
• Other study ID #: 08-031
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2009
• Est. completion date: February 20, 2017

Study information

• Verified date: April 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 20, 2017
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• JVRS-100
Level 1: 0.5 µg/Kg D1,8,15; Level 2: 1.0 µg/Kg D1,8,15; Level 3:2.0 µg/Kg 1,15; Level 4: 2.0 µg/Kg D1,8,15; Level 5: 4.0 µg/Kg D1,15
• JVRS-100
Change to Stage 2 with starting dose of 4.0 µg/Kg D1,8,15 if no toxicity level by Level 5.

Locations

Country	Name	City	State
United States	Penn State Hershey Cancer Institute	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of JVRS-100	Toxicities will be assessed on day 30 of cycle 1. Establish dose limiting toxicity and a maximum tolerated dose recommended Phase 2 dose.	Day 30 of cycle #1
Secondary	Define parameters of immune activation after JVRS-100 therapy.	Activation of peripheral blood cells including T-cell subsets, CD4+ and CD8+ cells, B-cells, and NK cells will be studied for activation markers including cell surface phenotypic changes, and expression of intracellular cytokines. Changes in circulating cytokine concentrations will be studied, as will functional properties of circulating immune effector and activating cells.	Day 30 of cycle #1