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

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 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.

Study Overview

• Status: Terminated
• Conditions: Perianal Warts
• Intervention / Treatment: Biological: Leukocyte Interleukin, Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134-5000
      • Naval Medical Center San Diego
    • San Francisco, California, United States, 94115
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥18 years of age
2. Diagnosed with perianal condyloma by primary clinician
3. 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.
4. Negative reaction to intradermal test with ciprofloxacin (a fluoroquinolone antibiotic)
5. Any CD4 count will be considered appropriate for study
6. Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500
7. Blood hemoglobin > 10.0 g/dL
8. Blood platelet count > 50x103/mm3
9. Serum total bilirubin < 6.0 mg/dL (participants taking atazanavir-based ARV regimens may have elevated total bilirubin but are generally < 6)
10. Blood aspartate aminotransferase (AST) < 100 U/L (<2 ULN)
11. Blood alanine aminotransferase (ALT) < 130 U/L (<2 ULN)
12. Serum creatinine < 1.5 mg/dL
13. ECOG performance status < 3
14. 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.
15. Subjects must be willing to refrain from anal sex, douching and use of enemas prior to scheduled Pap smears

Exclusion Criteria:

1. Anal cancer (current or history of)
2. Inability to attend study visits
3. Participation in any other drug study
4. History of asthma
5. 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)
6. History of organ transplantation or requiring chronic administration of immune suppressive drugs in the last 6 months
7. For women, neither pregnant nor lactating
8. In the opinion of the Primary Investigator, the subject may not be able to tolerate the study treatment regimen
9. Subjects who are currently using or have recently within past 3 months) been treated with immunomodulators (e.g., Interferon-α)
10. Subjects with active infections including sexually transmitted diseases (e.g., N. gonorrhea, C. trachomatis, H. ducreyi, T. pallidum)
11. History of allergic reaction to fluoroquinolone antibiotics (e.g., ciprofloxacin, ofloxacin)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.	Biological: Leukocyte Interleukin, Injection; Immunotherapy; Other Names: Multikine
Experimental: Arm B; Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.	Biological: Leukocyte Interleukin, Injection; Immunotherapy; Other Names: Multikine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of HPV subtype identification change	HPV subtyping will be performed on specimens collected from the anal canal.	Days 0, 4, 11, 32, 39, 70, 100 130, 160
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	Days 0, 4, 11, 32, 39, 70, 100, 130, 160
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	Days 0, 4, 11, 32, 39, 70, 100, 130, 160

Collaborators and Investigators

• Sponsor: CEL-SCI Corporation
• Collaborators: United States Naval Medical Center, San Diego; Ergomed Clinical Research Inc.
• Investigators: Study Director: Eyal Talor, PhD, CEL-SCI Chief Scientific Officer

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimated): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Warts; Condylomata Acuminata
• Other Study ID Numbers: NMCSD2013.008_UCSF - deleted

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO