Safety Study of Multikine in the Treatment of Perianal Warts

Condyloma Clinical Trial

Official title:

Phase 1 Study of Multikine in the Treatment of Perianal Warts

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02115919
• Other study ID #: NMCSD.2013.0080
• Status: Terminated
• Phase: Phase 1
• First received: August 15, 2013
• Last updated: August 17, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted infection (STI). They are distressing to those who have them and are a source of viral shedding and transmission to others. Treatment of warts is aimed at destruction of the lesion.

Objectives:

1. Establish safety of Multikine in treatment of perianal condyloma.

2. Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma.

3. Describe adverse effects associated with Multikine in the management of perianal condyloma.

Design:

Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal warts will be referred to study by their primary clinician. All participants will undergo baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count, measurement, photography), and complete a baseline questionnaire. Cohort A participants will undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using the same schedule but with a dose of 400IU per treatment. Each participant will undergo anal Pap and anal HPV subtyping once weekly during treatment. Condyloma characterization (count, measurement, photography) will occur prior to each treatment. After treatment completed, participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap, anal HPV subtyping, and perianal condyloma characterization (count, measurement, photography) performed.

Subjects:

The study will be open to adult men and women who are HIV-infected who receive medical care from the Naval Medical Center San Diego.

Main Outcome Measures:

1. Perianal wart characterization [count, measurement (in millimeters diameter)], photography)

2. HPV subtype in anal canal

3. Anal dysplasia cytologic grade

4. Questionnaire responses

5. Adverse effects experienced during treatment, recorded in symptom log

Description:

There are no further details to describe regarding this research project

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• Diagnosed with perianal condyloma by primary clinician

• HIV-infected, may be on or off of antiretroviral therapy

• 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 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.

Exclusion Criteria:

• Anal cancer (current or history of)

• Inability to attend study visits

• Participation in any other drug study

• History of asthma

• 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 PI, the subject may not be able to tolerate the study treatment regimen

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condyloma

Intervention

Drug:
• Leukocyte Interleukin, Injection 200IU
Cohort A participants will receive 200IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then 14 days off with out any Multikine injections received. After the 14 days without receiving the Investigational Product injections they will begin a second round of 200IU Multikine perilesional injections once daily, Monday through Friday for 14 days.
• Leukocyte Interleukin, injection 400IU
Cohort B participants will receive 400IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then they will not receive any Multikine perilesional injections for 14 days. After the 14 day rest period when the participants did not receive the Investigational Product injections they will begin a second round of 400IU Multikine perilesional injections every day, Monday through Friday, for 14 days.

Locations

Country	Name	City	State
United States	NMCSD	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	CEL-SCI Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wart characterization change is being assessed	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	Days 0, 4, 11, 32, 39, 70, 100, 130, 160	Yes
Secondary	HPV subtype identification change is being assessed	HPV subtype identification specimen collection from the anal canal will be conducted during the treatment phase and the follow-up phase of the study	Days 0, 4, 11, 32, 39, 70, 100, 130, 160	No
Secondary	Anal dysplasia cytologic grade change is being assessed	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	No
Secondary	Adverse effects during the treatment phase of the study are being 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	Yes