Perianal WartsPhase 1PAWNCT03038828
Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts
A Phase 1 study testing Leukocyte Interleukin, Injection in people with Perianal Warts, run by CEL-SCI Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Warts
- What is being tested?
- Leukocyte Interleukin, Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Naval Medical Center San Diego
San Diego, California, 92134-5000
University of California San Francisco
San Francisco, California, 94115
About this study
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
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.
Read the 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.
- Conditions
- Perianal Warts
- Being tested
- Leukocyte Interleukin, Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte Interleukin, InjectionBiological
Also called Multikine
Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Leukocyte Interleukin, Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
Secondary outcomes (3)
Assessment of HPV subtype identification change
HPV subtyping will be performed on specimens collected from the anal canal.
Measured: 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
Measured: 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
Measured: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startApr 2015
- Primary completionJun 2018
- Study completionSep 2018
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEL-SCI Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ergomed Clinical Research Inc., United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
- Investigators
- Eyal Talor, PhD, Study director, CEL-SCI Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038828
- Sponsor's protocol ID
- NMCSD2013.008_UCSF - deleted
- Acronym
- PAW
- Status last verified
- May 2022
- First submitted
- 8 Sep 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03038828
- Acronym / sponsor ID
- PAW / NMCSD2013.008_UCSF - deleted
- Conditions
- Perianal Warts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CEL-SCI CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Ergomed Clinical Research Inc., United States Naval Medical Center, San Diego
- Study start
- Apr 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Leukocyte Interleukin, InjectionCohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks. |
| Arm B | Experimental | Biological: Leukocyte Interleukin, InjectionArm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukocyte Interleukin, InjectionAlso: MultikineImmunotherapy | Biological | Arm A, Arm B |
Primary outcome
Wart characterization change
Time frame: 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
3 secondary outcomes
Assessment of HPV subtype identification change
Time frame: Days 0, 4, 11, 32, 39, 70, 100 130, 160
Assessment of Anal dysplasia cytologic grade change
Time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Assessment of adverse effects during the treatment phase of the study assessed
Time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Perianal Warts
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Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Talor, PhD study director
CEL-SCI Chief Scientific Officer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leukocyte Interleukin, Injection in people with Perianal Warts, run by CEL-SCI Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wart characterization change (time frame: Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.