Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04929028 · ClinicalTrials.gov registry record · Phase 2
Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer
A Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 14
- Study locations
NCT04929028 is a Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The trial reports 14 study locations across 9 states.
The verdict
NCT04929028, a Phase 2 study of HIV Infection and Stage III Rectal Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- PROCEDURE Anoscopy
- PROCEDURE Colonoscopy
Study Locations (14)
New York
- Mount Sinai West - New York
- Icahn School of Medicine at Mount Sinai - New York
- Mount Sinai Hospital - New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Texas
- Lyndon Baines Johnson General Hospital - Houston
- M D Anderson Cancer Center - Houston
California
- Zuckerberg San Francisco General Hospital - San Francisco
District of Columbia
- George Washington University Medical Center - Washington D.C.
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Illinois - Chicago
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- Pennsylvania Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2031-09-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04929028
The ClinicalTrials.gov registry entry for NCT04929028 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04929028 reports 14 study locations spanning 9 distinct geographic areas - top geographies include New York, Texas, California.
Frequently Asked Questions
What is clinical trial NCT04929028 about?
NCT04929028 is a clinical study titled "Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer". This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer...
What is the current status of trial NCT04929028?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-08-09. Estimated completion is 2031-09-15.
What conditions does trial NCT04929028 study?
This clinical trial studies the following conditions: HIV Infection, Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Anal Squamous Cell Carcinoma, Anal Margin Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04929028?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Anoscopy (PROCEDURE), Colonoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT04929028?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04929028 being conducted?
This trial has 14 study locations across California, District of Columbia, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
ACTIVE NOT RECRUITING · Phase 2
-
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
COMPLETED · Phase 2
-
Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
COMPLETED · Phase 2
-
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
COMPLETED · Phase 2
-
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
COMPLETED · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.