Safety Study of Multikine in the Treatment of Perianal Warts

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by United States Naval Medical Center, San Diego
Sponsor:
Collaborator:
CEL-SCI Corporation
Information provided by (Responsible Party):
John D. Malone, M.D., United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT02115919
First received: August 15, 2013
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted infection (STI). They are distressing to those who have them and are a source of viral shedding and transmission to others. Treatment of warts is aimed at destruction of the lesion.

Objectives:

  1. Establish safety of Multikine in treatment of perianal condyloma.
  2. Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma.
  3. Describe adverse effects associated with Multikine in the management of perianal condyloma.

Design:

Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal warts will be referred to study by their primary clinician. All participants will undergo baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count, measurement, photography), and complete a baseline questionnaire. Cohort A participants will undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using the same schedule but with a dose of 400IU per treatment. Each participant will undergo anal Pap and anal HPV subtyping once weekly during treatment. Condyloma characterization (count, measurement, photography) will occur prior to each treatment. After treatment completed, participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap, anal HPV subtyping, and perianal condyloma characterization (count, measurement, photography) performed.

Subjects:

The study will be open to adult men and women who are HIV-infected who receive medical care from the Naval Medical Center San Diego.

Main Outcome Measures:

  1. Perianal wart characterization [count, measurement (in millimeters diameter)], photography)
  2. HPV subtype in anal canal
  3. Anal dysplasia cytologic grade
  4. Questionnaire responses
  5. Adverse effects experienced during treatment, recorded in symptom log

Condition Intervention Phase
Condyloma
Drug: Leukocyte Interleukin, Injection 200IU
Drug: Leukocyte Interleukin, injection 400IU
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Multikine in the Treatment of Perianal Warts

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Wart characterization change is being assessed [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ] [ Designated as safety issue: Yes ]
    Perianal wart characterization includes counting the number of identified warts, the diameter measurement of each identified wart in millimeters and the photographic imaging of each identified wart during the treatment phase and the follow-up phase of the study


Secondary Outcome Measures:
  • HPV subtype identification change is being assessed [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ] [ Designated as safety issue: No ]
    HPV subtype identification specimen collection from the anal canal will be conducted during the treatment phase and the follow-up phase of the study

  • Anal dysplasia cytologic grade change is being assessed [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ] [ Designated as safety issue: No ]
    Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study

  • Adverse effects during the treatment phase of the study are being assessed [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ] [ Designated as safety issue: Yes ]
    Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log


Estimated Enrollment: 15
Study Start Date: April 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Cohort A participants will undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days.
Drug: Leukocyte Interleukin, Injection 200IU
Cohort A participants will receive 200IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then 14 days off with out any Multikine injections received. After the 14 days without receiving the Investigational Product injections they will begin a second round of 200IU Multikine perilesional injections once daily, Monday through Friday for 14 days.
Other Name: Multikine, Injection 200IU
Experimental: Cohort B
Cohort B participants will undergo perilesional Multikine injections 400IU once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days.
Drug: Leukocyte Interleukin, injection 400IU
Cohort B participants will receive 400IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then they will not receive any Multikine perilesional injections for 14 days. After the 14 day rest period when the participants did not receive the Investigational Product injections they will begin a second round of 400IU Multikine perilesional injections every day, Monday through Friday, for 14 days.
Other Name: Multikine, Injection 400IU

Detailed Description:

There are no further details to describe regarding this research project

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • Diagnosed with perianal condyloma by primary clinician
  • HIV-infected, may be on or off of antiretroviral therapy
  • any CD4 count will be considered appropriate for study
  • Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500
  • Blood hemoglobin > 10.0 g/dL
  • Blood platelet count > 50x103/mm3
  • Serum total bilirubin < 6.0 mg/dL (participants taking atazanavir-based ARV regimens may have elevated total bilirubin but are generally < 6)
  • Blood aspartate aminotransferase (AST) < 100 U/L (<2 ULN)
  • Blood alanine aminotransferase (ALT) < 130 U/L (<2 ULN)
  • Serum creatinine < 1.5 mg/dL
  • ECOG performance status < 3
  • If a subject is of reproductive potential he/she and her/his sexual partner MUST be willing and able to utilize effective methods of contraception (e.g., birth control pill, barrier methods with spermicide - as applicable) for the duration of the study including the study follow-up period.

Exclusion Criteria:

  • Anal cancer (current or history of)
  • Inability to attend study visits
  • Participation in any other drug study
  • History of asthma
  • History of organ transplantation or requiring chronic administration of immune suppressive drugs in the last 6 months
  • For women, neither pregnant nor lactating
  • In the opinion of the PI, the subject may not be able to tolerate the study treatment regimen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115919

Contacts
Contact: Patricia Schiffler 619-532-6251 patricia.schiffler@med.navy.mil

Locations
United States, California
NMCSD Recruiting
San Diego, California, United States, 92134
Contact: Patricia J Schiffler, CTR    619-532-6251    patricia.schiffler.ctr@med.navy.mil   
Principal Investigator: John D Malone, MD         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
CEL-SCI Corporation
Investigators
Principal Investigator: John D Malone, MD NMCSD
  More Information

No publications provided

Responsible Party: John D. Malone, M.D., PI, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02115919     History of Changes
Other Study ID Numbers: NMCSD.2013.0080
Study First Received: August 15, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by United States Naval Medical Center, San Diego:
condyloma
HIV

ClinicalTrials.gov processed this record on October 20, 2014