Anal Cancer Clinical Trial
Official title:
A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals
Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in preventing anal cancer.
OBJECTIVES:
I. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients
with high-grade anal squamous intraepithelial lesions.
II. Determine clinical response and histologic/cytologic regression in patients treated with
this drug.
III. Determine immune response in patients treated with this drug. IV. Determine the effect
of this drug on HIV viral load and CD4 level in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in
the absence of disease progression or unacceptable toxicity.
Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6
patients experience dose-limiting toxicity.
Patients are followed at 1, 4, and 10 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05060471 -
PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients
|
Phase 2 | |
| Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
| Completed |
NCT05518201 -
Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old
|
Phase 1 | |
| Withdrawn |
NCT02857608 -
A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
|
Phase 2 | |
| Active, not recruiting |
NCT02546973 -
Quality of Life in Patients With Anal Cancer
|
||
| Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
| Completed |
NCT00550589 -
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
|
Phase 2 | |
| Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
| Completed |
NCT00324415 -
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
|
Phase 2 | |
| Terminated |
NCT00568425 -
QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT
|
||
| Terminated |
NCT00267787 -
Molecular Genetic and Pathological Studies of Anal Tumors
|
||
| Completed |
NCT00066430 -
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
|
Phase 1 | |
| Completed |
NCT04083053 -
High-Resolution Anoscopy Perceived Discomfort Study
|
N/A | |
| Completed |
NCT03506529 -
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
|
||
| Recruiting |
NCT05835947 -
Anal Cancer Risk In Women
|
||
| Not yet recruiting |
NCT03947775 -
HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL
|
Phase 2 | |
| Recruiting |
NCT04857528 -
Detecting HPV DNA in Anal and Cervical Cancers
|
||
| Recruiting |
NCT04907643 -
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
|
N/A | |
| Recruiting |
NCT04708470 -
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01937780 -
Anal Cancer Radiotherapy Study
|