Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

NCT03038828 | Terminated Phase 1

• 1 other identifier: NMCSD2013.008_UCSF - deleted
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Perianal Warts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of HPV subtype identification change

  Days 0, 4, 11, 32, 39, 70, 100 130, 160

• Assessment of Anal dysplasia cytologic grade change

  Days 0, 4, 11, 32, 39, 70, 100, 130, 160

• Assessment of adverse effects during the treatment phase of the study assessed

  Days 0, 4, 11, 32, 39, 70, 100, 130, 160

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

EXPERIMENTAL

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

Interventions

Leukocyte Interleukin, Injection BIOLOGICAL

Immunotherapy

Also known as: Multikine

Arm A; Arm B

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CEL-SCI Corporation: lead
• Ergomed Clinical Research Inc.: collaborator
• United States Naval Medical Center, San Diego: collaborator

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134-5000, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Eyal Talor, PhD

  CEL-SCI Chief Scientific Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: February 1, 2017
• Study Start: April 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 22, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)