search
Back to results

Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts (PAW)

Primary Purpose

Perianal Warts

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Leukocyte Interleukin, Injection
Sponsored by
CEL-SCI Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Perianal Warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥18 years of age Diagnosed with perianal condyloma by primary clinician HIV-infected, may be on or off of antiretroviral therapy. Enrolment of subjects on HAART will be restricted to those individuals for whom an alternative regimen can reasonably be constructed in case of failure. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone antibiotic) 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 highly 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. Subjects must be willing to refrain from anal sex, douching and use of enemas prior to scheduled Pap smears Exclusion Criteria: Anal cancer (current or history of) Inability to attend study visits Participation in any other drug study History of asthma History of CHF and/or cardiac support for arrhythmia or on chronic cardiac medication or has other chronic or acute cardiac ailments (e.g., or abnormal EKG at Baseline) 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 Primary Investigator, the subject may not be able to tolerate the study treatment regimen Subjects who are currently using or have recently within past 3 months) been treated with immunomodulators (e.g., Interferon-α) Subjects with active infections including sexually transmitted diseases (e.g., N. gonorrhea, C. trachomatis, H. ducreyi, T. pallidum) History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin, ofloxacin)

Sites / Locations

  • Naval Medical Center San Diego
  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.

Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.

Outcomes

Primary Outcome Measures

Wart characterization change
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

Assessment of HPV subtype identification change
HPV subtyping will be performed on specimens collected from the anal canal.
Assessment of Anal dysplasia cytologic grade change
Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study
Assessment of adverse effects during the treatment phase of the study assessed
Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log

Full Information

First Posted
September 8, 2016
Last Updated
September 21, 2023
Sponsor
CEL-SCI Corporation
Collaborators
Ergomed Clinical Research Inc., United States Naval Medical Center, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT03038828
Brief Title
Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts
Acronym
PAW
Official Title
Phase 1 Dose Escalation Study to Establish the Safety of Leukocyte Interleukin, Injection for Treatment of Perianal Warts in Adult Men and Women Who Are HIV/HPV Co-infected
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEL-SCI Corporation
Collaborators
Ergomed Clinical Research Inc., United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are noted in cohort A patients, ten participants will be treated in cohort B. Cohort B participants will be treated the same as cohort A participants except that dose will be increased to 400IU Multikine per day.
Detailed Description
Study is a dose escalation study to determine the safety of Leukocyte Interleukin, Injection in treating men and women with perianal warts who are HIV/HPV co-infected. Fifteen patients will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then treated again 5 days/week for 2 weeks. If no serious adverse events are noted in cohort A patients, ten (10) participants will be treated in cohort B. Cohort B participants will be treated in the same manner as cohort A participants except that the dose will be increased to 400IU Multikine per day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Warts

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.
Intervention Type
Biological
Intervention Name(s)
Leukocyte Interleukin, Injection
Other Intervention Name(s)
Multikine
Intervention Description
Immunotherapy
Primary Outcome Measure Information:
Title
Wart characterization change
Description
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
Time Frame
Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
Secondary Outcome Measure Information:
Title
Assessment of HPV subtype identification change
Description
HPV subtyping will be performed on specimens collected from the anal canal.
Time Frame
Days 0, 4, 11, 32, 39, 70, 100 130, 160
Title
Assessment of Anal dysplasia cytologic grade change
Description
Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study
Time Frame
Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Title
Assessment of adverse effects during the treatment phase of the study assessed
Description
Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log
Time Frame
Days 0, 4, 11, 32, 39, 70, 100, 130, 160

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years of age Diagnosed with perianal condyloma by primary clinician HIV-infected, may be on or off of antiretroviral therapy. Enrolment of subjects on HAART will be restricted to those individuals for whom an alternative regimen can reasonably be constructed in case of failure. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone antibiotic) 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 highly 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. Subjects must be willing to refrain from anal sex, douching and use of enemas prior to scheduled Pap smears Exclusion Criteria: Anal cancer (current or history of) Inability to attend study visits Participation in any other drug study History of asthma History of CHF and/or cardiac support for arrhythmia or on chronic cardiac medication or has other chronic or acute cardiac ailments (e.g., or abnormal EKG at Baseline) 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 Primary Investigator, the subject may not be able to tolerate the study treatment regimen Subjects who are currently using or have recently within past 3 months) been treated with immunomodulators (e.g., Interferon-α) Subjects with active infections including sexually transmitted diseases (e.g., N. gonorrhea, C. trachomatis, H. ducreyi, T. pallidum) History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin, ofloxacin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Talor, PhD
Organizational Affiliation
CEL-SCI Chief Scientific Officer
Official's Role
Study Director
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-5000
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

We'll reach out to this number within 24 hrs