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Trial record 1 of 1 for:    NCT03038828
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Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts (PAW)

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ClinicalTrials.gov Identifier: NCT03038828
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : February 1, 2017
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Ergomed Clinical Research Inc.
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
CEL-SCI Corporation

Tracking Information
First Submitted Date  ICMJE September 8, 2016
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date February 11, 2019
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Assessment of HPV subtype identification change [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100 130, 160 ]
    HPV subtyping will be performed on specimens collected from the anal canal.
  • Assessment of Anal dysplasia cytologic grade change [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
    Anal dysplasia cytologic specimen collection will take place during the treatment phase and the follow-up phase of the study
  • Assessment of adverse effects during the treatment phase of the study assessed [ Time Frame: Days 0, 4, 11, 32, 39, 70, 100, 130, 160 ]
    Adverse effects experienced during the treatment phase of the study are recorded by the study participants in a symptoms log
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Perianal Warts
Intervention  ICMJE Biological: Leukocyte Interleukin, Injection
Immunotherapy
Other Name: Multikine
Study Arms  ICMJE
  • Experimental: Arm A
    Cohort A - 200IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off two weeks, then repeat 200IU 5 days/week x 2 weeks.
    Intervention: Biological: Leukocyte Interleukin, Injection
  • Experimental: Arm B
    Arm B - 400IU Leukocyte Interleukin, Injection 5 days/week x 2 weeks, off 2 weeks, 400IU 5 days/week x 2 weeks.
    Intervention: Biological: Leukocyte Interleukin, Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
15
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-α)
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03038828
Other Study ID Numbers  ICMJE NMCSD2013.008_UCSF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CEL-SCI Corporation
Study Sponsor  ICMJE CEL-SCI Corporation
Collaborators  ICMJE
  • Ergomed Clinical Research Inc.
  • United States Naval Medical Center, San Diego
Investigators  ICMJE
Study Director: Eyal Talor, PhD CEL-SCI Chief Scientific Officer
PRS Account CEL-SCI Corporation
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP