Low Dose Cyclophosphamide Treats Genital Warts

This study has been completed.
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00999986
First received: October 21, 2009
Last updated: November 24, 2009
Last verified: November 2009
  Purpose

Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year. Recurrence is a major challenge for CA treatment. The investigators have demonstrated that FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose cyclophosphamide was given.


Condition Intervention Phase
Genital Wart
Drug: cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: placebo
Active Comparator: cyclophosphamide Drug: cyclophosphamide
50 mg oral per day for 7 days
Other Name: CY

Detailed Description:

Patients were first treated with CO2 laser therapy, and then treated with low-dose CY, orally 50 mg per day for 7 days.The CA recurrence were observed.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of large genital warts

Exclusion Criteria:

  • HPV type 6 or 11 was detected negatively by PCR method.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999986

Locations
China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Principal Investigator: Bo Huang, PH.D, MD Tongji Medical College
  More Information

Publications:
Responsible Party: Feifan Meng, Sheng-Qi-An Biotech Inc
ClinicalTrials.gov Identifier: NCT00999986     History of Changes
Other Study ID Numbers: Sheng-Qi-An
Study First Received: October 21, 2009
Last Updated: November 24, 2009
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 01, 2014