Cervical Squamous Cell Carcinoma In SituPhase 2NCT03267680
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
A Phase 2 study testing Cyclophosphamide, Indomethacin and IRX-2 in people with Cervical Squamous Cell Carcinoma In Situ and Vulvar High Grade Squamous Intraepithelial Lesion, run by University of Southern California at 2 sites in United States.
Trial summary
This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion
- What is being tested?
- Cyclophosphamide, Indomethacin and IRX-2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2017to 13 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous CIN 3, or VIN 3 (usual type only)
- The subject is either surgically sterile, postmenopausal, or agrees to practice an effective method of birth control as determined by the investigator (to be continued throughout the study period), except that subjects with CIN 3 are not permitted to use a cervical cap or diaphragm for contraception
- White blood cell > 2,500/ mcL (> 2.5 x 10^9/L)
- Absolute neutrophil count > 1,000/ microliter (> 1 x 10^9/L)
- Platelet count > 75,000/ mcL (> 75 x 10^9/L)
- Hemoglobin >= 8 g/dL (>= 80 g/L) (subjects who have received a transfusion or erythropoietin up to one week prior to receiving the first dose of cyclophosphamide are eligible for the study)
Show all 13Show fewer
- International normalized ration (INR) or prothrombin time (PT) < 1.5 x ULN (upper limit of normal)
- Activated partial thromboplastin time (aPTT) < 1.5 x ULN
- Serum creatinine < 1.5 x ULN
- Total bilirubin < 2.0 x ULN unless thought to be related to inherited bilirubin conjugation disorder (ie Gilbert?s disease)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN
- The subject is geographically accessible for ongoing follow-up and is committed to comply with the designated visits
- The subject is capable of understanding and complying with the protocol and has signed the enrollment informed consent form at screening
Who cannot join
- For subjects with cervical dysplasia: evidence of atypical glandular cells or adenocarcinoma in situ (ACIS) based on cervical cytology, colposcopy or biopsy
- For subjects with either cervical or vulvar squamous dysplasia: evidence of microinvasive squamous carcinoma based on cytology, colposcopy or biopsy
- Pregnancy or lactation
- Allergy to ciprofloxacin or other quinolones (because ciprofloxacin is used in preparation of IRX-2)
- Allergy to indomethacin (a necessary component of the regimen) or to acetylsalicylic acid (aspirin) due to likely allergy cross-reaction
- Aldara (imiquimod) for the topical treatment of lower genital tract warts or dysplasia within 3 months of study enrollment
Show all 19Show fewer
- Known to be positive for human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody
- Known to have other immunodeficiency diseases, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia
- Immunotherapy (eg, interferons, tumor necrosis factor, interleukins) or biological response modifiers (granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor) or any investigational drug within 3 months of study enrollment
- Concurrent treatment with systemic corticosteroids at a dose of >= 5 mg/day of prednisone (or equivalent)
- Subjects should not take aspirin (except for low-dose aspirin as prescribed for vascular disease) or other non-prescribed, non-steroidal anti-inflammatory agents from randomization to surgery
- An infectious process or any other significant illness such as an autoimmune disease or advanced age that in the opinion of the investigator would compromise the subject?s ability to mount an immune response
- Impaired hepatic, renal or hematological function, evidenced by:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >= 2 times upper limit of normal (ULN),
- Serum creatinine >= 2 times ULN, or
- Clinically significant active cardiovascular disease, including a history of myocardial infarction within the past 6 months, heart failure as defined by New York Heart Association classes III or IV, and/or blood pressure greater than 160/90 mm Hg (1 repeat measure allowed no more than 5 minutes after the first measurement)
- History of severe allergic reaction to insect bites or stings, or to any biologic pharmaceutical product, including compounds similar to the test article
- Any medical contraindications, allergies or previous therapy that would preclude treatment with the components of the IRX-2 regimen, i.e., cyclophosphamide, indomethacin, zinc-containing multivitamins or omeprazole
- Donation or loss of > 450 mL of blood or plasma within 30 days of randomization
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Two-Cohort, Open-label Phase 2 Trial of the IRX-2 Regimen in Women With Squamous Cervical Intraepithelial Neoplasia 3 (CIN 3) or Vulvar Intraepithelial Neoplasia 3 (VIN 3)
This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived biologic with multiple active cytokine components, may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the proportion of subjects who achieve a pathologic complete response (CR) or partial response (PR) in regimen 1 versus regimen 2 at week 25, based on the resected surgical specimen.
SECONDARY OBJECTIVES:
- To evaluate the toxicity and feasibility of administration of IRX-2 in subjects with confirmed cervical intraepithelial neoplasia (CIN) 3 or vulvar intraepithelial neoplasia (VIN) 3.
II. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: the occurrence of clinical CRs or PRs at weeks 6, 13 and 25.
III. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: frequency of elimination of human papillomavirus (HPV) in cervical or vulvar tissue using a commercial HPV genotyping assay and viral load determination by quantitative polymerase chain reaction (PCR).
IV. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: analysis of the immune infiltrates in the resected surgical specimens.
- To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: immunophenotypic analysis of peripheral blood lymphocytes.
VI. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: frequency of serum antibodies to HPV E6, E7 and L1 proteins by enzyme-linked immunosorbent assay (ELISA).
VII. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: ribonucleic acid (RNA) expression profiling of immune-inflammatory markers from post-treatment resected surgical specimens.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive cyclophosphamide intravenously (IV) on day 1 and IRX-2 via submucosal injections in the cervix or subcutaneously (SC) for vulvar lesions on days 4-7. Patients also receive indomethacin orally (PO) three times daily (TID), zinc-containing multivitamins (PO) once daily (QD) and omeprazole orally (PO) on days 1-21.
Arm II: Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21.
In both arms, treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.
After completion of study treatment, patients are followed up at 1-8 weeks after surgery.
- Conditions
- Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion
- Being tested
- Cyclophosphamide, Indomethacin, IRX-2, Laboratory Biomarker Analysis, Multivitamin
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Given IV
IndomethacinDrug
Given PO
IRX-2Biological
Given via submucosal injection or SC
Laboratory Biomarker AnalysisOther
Correlative studies
MultivitaminDietary supplement
Also called Geritol, Vitamin Supplements (NOS)
Given zinc-containing multivitamin PO
OmeprazoleDrug
Given PO
PlaceboOther
Also called placebo therapy, sham therapy
Given via submucosal injections or SC
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (IRX-2) | Experimental | Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Receives: Drug: Cyclophosphamide; Drug: Indomethacin; Biological: IRX-2; Other: Laboratory Biomarker Analysis; Dietary Supplement: Multivitamin; Drug: Omeprazole; Procedure: Therapeutic Conventional Surgery |
| Arm II (placebo) | Active comparator | Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Receives: Drug: Cyclophosphamide; Drug: Indomethacin; Other: Laboratory Biomarker Analysis; Dietary Supplement: Multivitamin; Drug: Omeprazole; Other: Placebo; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Response
Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).
Measured: Week 25
Secondary outcomes (1)
Incidence of Adverse Events of IRX-2 Administration
Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start8 Nov 2017
- Primary completion4 Aug 2023
- Study completion13 Mar 2024
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Squamous Cell Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Brooklyn ImmunoTherapeutics, LLC
- Responsible party
- Sponsor
- Investigators
- Lynda Roman, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267680
- Sponsor's protocol ID
- 5GYN-16-2
- Other IDs
- NCI-2017-01402, 5GYN-16-2, P30CA014089
- Status last verified
- Mar 2025
- First submitted
- 28 Aug 2017
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Cohort, Open-label Phase 2 Trial of the IRX-2 Regimen in Women With Squamous Cervical Intraepithelial Neoplasia 3 (CIN 3) or Vulvar Intraepithelial Neoplasia 3 (VIN 3)
- ClinicalTrials.gov ID
- NCT03267680
- Acronym / sponsor ID
- 5GYN-16-2
- Conditions
- Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Brooklyn ImmunoTherapeutics, LLC
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 13 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived biologic with multiple active cytokine components, may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.
Detailed description
PRIMARY OBJECTIVES:
- To compare the proportion of subjects who achieve a pathologic complete response (CR) or partial response (PR) in regimen 1 versus regimen 2 at week 25, based on the resected surgical specimen.
SECONDARY OBJECTIVES:
- To evaluate the toxicity and feasibility of administration of IRX-2 in subjects with confirmed cervical intraepithelial neoplasia (CIN) 3 or vulvar intraepithelial neoplasia (VIN) 3.
II. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: the occurrence of clinical CRs or PRs at weeks 6, 13 and 25.
III. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: frequency of elimination of human papillomavirus (HPV) in cervical or vulvar tissue using a commercial HPV genotyping assay and viral load determination by quantitative polymerase chain reaction (PCR).
IV. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: analysis of the immune infiltrates in the resected surgical specimens.
- To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: immunophenotypic analysis of peripheral blood lymphocytes.
VI. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: frequency of serum antibodies to HPV E6, E7 and L1 proteins by enzyme-linked immunosorbent assay (ELISA).
VII. To evaluate multiple parameters to assess the activity of the IRX-2 regimen for the treatment of CIN 3 or VIN 3: ribonucleic acid (RNA) expression profiling of immune-inflammatory markers from post-treatment resected surgical specimens.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive cyclophosphamide intravenously (IV) on day 1 and IRX-2 via submucosal injections in the cervix or subcutaneously (SC) for vulvar lesions on days 4-7. Patients also receive indomethacin orally (PO) three times daily (TID), zinc-containing multivitamins (PO) once daily (QD) and omeprazole orally (PO) on days 1-21.
Arm II: Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21.
In both arms, treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.
After completion of study treatment, patients are followed up at 1-8 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (IRX-2) | Experimental | Drug: Cyclophosphamide, Drug: Indomethacin, Biological: IRX-2, Other: Laboratory Biomarker Analysis, Dietary Supplement: Multivitamin, Drug: Omeprazole, Procedure: Therapeutic Conventional SurgeryPatients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. |
| Arm II (placebo) | Active comparator | Drug: Cyclophosphamide, Drug: Indomethacin, Other: Laboratory Biomarker Analysis, Dietary Supplement: Multivitamin, Drug: Omeprazole, Other: Placebo, Procedure: Therapeutic Conventional SurgeryPatients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed squamous CIN 3, or VIN 3 (usual type only)
- The subject is either surgically sterile, postmenopausal, or agrees to practice an effective method of birth control as determined by the investigator (to be continued throughout the study period), except that subjects with CIN 3 are not permitted to use a cervical cap or diaphragm for contraception
- White blood cell > 2,500/ mcL (> 2.5 x 10^9/L)
- Absolute neutrophil count > 1,000/ microliter (> 1 x 10^9/L)
- Platelet count > 75,000/ mcL (> 75 x 10^9/L)
Key exclusion criteria (19 listed)
- For subjects with cervical dysplasia: evidence of atypical glandular cells or adenocarcinoma in situ (ACIS) based on cervical cytology, colposcopy or biopsy
- For subjects with either cervical or vulvar squamous dysplasia: evidence of microinvasive squamous carcinoma based on cytology, colposcopy or biopsy
- Pregnancy or lactation
- Allergy to ciprofloxacin or other quinolones (because ciprofloxacin is used in preparation of IRX-2)
- Allergy to indomethacin (a necessary component of the regimen) or to acetylsalicylic acid (aspirin) due to likely allergy cross-reaction
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 |
|---|---|---|
| CyclophosphamideGiven IV | Drug | Arm I (IRX-2), Arm II (placebo) |
| IndomethacinGiven PO | Drug | Arm I (IRX-2), Arm II (placebo) |
| IRX-2Given via submucosal injection or SC | Biological | Arm I (IRX-2) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (IRX-2), Arm II (placebo) |
| MultivitaminAlso: Geritol, Vitamin Supplements (NOS)Given zinc-containing multivitamin PO | Dietary supplement | Arm I (IRX-2), Arm II (placebo) |
| OmeprazoleGiven PO | Drug | Arm I (IRX-2), Arm II (placebo) |
| PlaceboAlso: placebo therapy, sham therapyGiven via submucosal injections or SC | Other | Arm II (placebo) |
| Therapeutic Conventional SurgeryUndergo surgical resection | Procedure or surgery | Arm I (IRX-2), Arm II (placebo) |
Primary outcome
Pathologic Response
Time frame: Week 25
Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).
1 secondary outcome
Incidence of Adverse Events of IRX-2 Administration
Time frame: Up to 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Squamous Cell Carcinoma In Situ
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Not yet recruitingPhase 2
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
Cervical Intraepithelial Neoplasia Grade 3
Recruiting
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2
Active, not recruitingPhase 2
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma In Situ
Not yet recruitingPhase 2
Evaluation of NWRD09 for HPV-16 Related Cervical HSIL
High-grade Squamous Intraepithelial Lesion (HSIL)
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.
Lynda Roman, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Indomethacin and IRX-2 in people with Cervical Squamous Cell Carcinoma In Situ and Vulvar High Grade Squamous Intraepithelial Lesion, run by University of Southern California 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 13 inclusion and 19 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 13 Apr 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pathologic Response (time frame: Week 25). 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 13 Apr 2025.