CondylomaPhase 1NCT02115919
Safety Study of Multikine in the Treatment of Perianal Warts
A Phase 1 study testing Leukocyte Interleukin, Injection 200IU and Leukocyte Interleukin, injection 400IU in people with Condyloma, run by United States Naval Medical Center, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Condyloma
- What is being tested?
- Leukocyte Interleukin, Injection 200IU and Leukocyte Interleukin, injection 400IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2016
- 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
- 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
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- 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.
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 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Multikine in the Treatment of Perianal Warts
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:
Read more
- Establish safety of Multikine in treatment of perianal condyloma.
- Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma.
- 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:
- Perianal wart characterization [count, measurement (in millimeters diameter)], photography)
- HPV subtype in anal canal
- Anal dysplasia cytologic grade
- Questionnaire responses
- Adverse effects experienced during treatment, recorded in symptom log
Read the detailed description
There are no further details to describe regarding this research project
- Conditions
- Condyloma
- Being tested
- Leukocyte Interleukin, Injection 200IU, Leukocyte Interleukin, injection 400IU
- Keywords
- condyloma, HIV
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte Interleukin, Injection 200IUDrug
Also called Multikine, 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 400IUDrug
Also called Multikine, 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 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. Receives: Drug: Leukocyte Interleukin, Injection 200IU |
| Cohort B | Experimental | Cohort B participants will undergo perilesional Multikine injections 400IU once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days. Receives: Drug: Leukocyte Interleukin, injection 400IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Secondary outcomes (3)
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
Measured: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
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
Measured: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
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
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 posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Unable to enroll prospective subject for dose escalation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CondylomaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- CEL-SCI Corporation
- Responsible party
- Sponsor
- Investigators
- John D Malone, MD, Principal investigator, NMCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115919
- Sponsor's protocol ID
- NMCSD.2013.0080
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2013
- Last updated
- 19 Aug 2016
- 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 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Multikine in the Treatment of Perianal Warts
- ClinicalTrials.gov ID
- NCT02115919
- Acronym / sponsor ID
- NMCSD.2013.0080
- Conditions
- Condyloma
- Keywords
- condyloma, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll prospective subject for dose escalation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- CEL-SCI Corporation
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Apr 2014 (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.
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:
- Establish safety of Multikine in treatment of perianal condyloma.
- Describe presence of anal HPV and anal dysplasia in participants with perianal condyloma.
- 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:
- Perianal wart characterization [count, measurement (in millimeters diameter)], photography)
- HPV subtype in anal canal
- Anal dysplasia cytologic grade
- Questionnaire responses
- Adverse effects experienced during treatment, recorded in symptom log
Detailed description
There are no further details to describe regarding this research project
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Leukocyte Interleukin, Injection 200IUCohort 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. |
| Cohort B | Experimental | Drug: Leukocyte Interleukin, injection 400IUCohort B participants will undergo perilesional Multikine injections 400IU once daily, Monday through Friday, for 14 days, off for 14 days, then again once daily, Monday through Friday for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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
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, Injection 200IUAlso: Multikine, Injection 200IUCohort 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. | Drug | Cohort A |
| Leukocyte Interleukin, injection 400IUAlso: Multikine, Injection 400IUCohort 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. | Drug | Cohort B |
Primary outcome
Wart characterization change is being assessed
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
HPV subtype identification change is being assessed
Time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Anal dysplasia cytologic grade change is being assessed
Time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Adverse effects during the treatment phase of the study are being assessed
Time frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160
Results and safety
The study was stopped early (reason given: Unable to enroll prospective subject for dose escalation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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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.
John D Malone, MD principal investigator
NMCSD
1 site 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 200IU and Leukocyte Interleukin, injection 400IU in people with Condyloma, run by United States Naval Medical Center, San Diego at 1 site 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 13 inclusion and 7 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Unable to enroll prospective subject for dose escalation). 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 is being assessed (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 19 Aug 2016.