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

NCT00860522 | Completed Phase 1 DMC

• 1 other identifier: 08-031
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

relapsed leukemia; refractory leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Define parameters of immune activation after JVRS-100 therapy.

  Day 30 of cycle #1

Study Arms (2)

Phase I

EXPERIMENTAL

Three patients will be enrolled at dose Level 1. If the patient does not completed the three infusion of JVRS-100 during cycle 1 for reason other than toxicity, another patient will be accrued at the same dose level.

Drug: JVRS-100

Phase II

EXPERIMENTAL

3 patients will be enrolled at a given dose level. If one of these patients experiences a dose limiting toxicity, an additional 3 patients will be enrolled at the given dose level. If the 1st 2 subjects enrolled and treated at a given dose experience dose limiting toxicities, no additional subjects will be enrolled at that dose. Dose escalation may proceed if \< 2/6 patients at a given dose level experience a LDT. If ≥ 2/6 patients experience a DLT at a given dose level, the next lower dose level will be considered the RP2D. If a patient does not complete the 3 infusions of JVRS-100 during Cycle 1 for reasons other than toxicity, another patient will be accrued at the same dose level. Once the RP2D is established, the cohort will be expanded to a total of 12 patients.

Drug: JVRS-100

Interventions

JVRS-100 DRUG

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

Also known as: Cationic liposome, Plasmid DNA complex

Phase I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• David F Claxton, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: March 1, 2009
• Primary Completion: October 31, 2014
• Study Completion: February 20, 2017
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)