Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

Perianal Warts Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03038828
• Other study ID #: NMCSD2013.008_UCSF - deleted
• Status: Terminated
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: September 2018

Study information

• Verified date: May 2022
• Source: CEL-SCI Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a)

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)

Related Conditions & MeSH terms

• Condylomata Acuminata
• Perianal Warts
• Warts

Intervention

Biological:
• Leukocyte Interleukin, Injection
Immunotherapy

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
CEL-SCI Corporation	Ergomed Clinical Research Inc., United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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