Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

Phase 1

Terminated

• Conditions: Perianal Warts
• Interventions: Biological: Leukocyte Interleukin, Injection

• Registration Number: NCT03038828
• Lead Sponsor: CEL-SCI Corporation

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2018-06
• Study Completion: 2018-09
• Status Verified: 2022-05
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm B	Leukocyte Interleukin, Injection	Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.
Arm A	Leukocyte Interleukin, Injection	Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.

Primary Outcome Measures

Name	Time	Method
Wart characterization change	Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]	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

Name	Time	Method
Assessment of Anal dysplasia cytologic grade change	Days 0, 4, 11, 32, 39, 70, 100, 130, 160	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	Days 0, 4, 11, 32, 39, 70, 100, 130, 160	Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log
Assessment of HPV subtype identification change	Days 0, 4, 11, 32, 39, 70, 100 130, 160	HPV subtyping will be performed on specimens collected from the anal canal.

Trial Locations

Locations (2)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States