AIDS-related Kaposi Sarcoma Clinical Trial
Official title:
A Phase II Trial of Topical Halofuginone in Patients With HIV Related Kaposi's Sarcoma
This phase II trial studies how well halofuginone hydrobromide works in treating patients with human immunodeficiency virus (HIV)-related Kaposi's sarcoma. Halofuginone hydrobromide ointment may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To determine the tumor response rate of acquired immune deficiency syndrome
(AIDS)-related Kaposi's sarcoma to topical halofuginone (halofuginone hydrobromide) versus
vehicle control.
II. To evaluate the safety and tolerability of topical halofuginone and vehicle in patients
with AIDS-related Kaposi's sarcoma.
SECONDARY OBJECTIVES:
I. To determine the ability of topical halofuginone to inhibit expression of matrix
metallopeptidase 2 (MMP-2) and Collagen type I in AIDS-related Kaposi's sarcoma.
II. To explore the relationship between baseline cluster of differentiation (CD) 4 and CD8
counts, HIV viral load and human herpesvirus 8 (HHV-8) viral load and response to
halofuginone.
III. To characterize the pharmacokinetics of halofuginone.
OUTLINE: Twelve treatable Kaposi's sarcoma lesions are selected on each patient, and these
12 lesions are randomized equally to 1 of 2 treatment arms (6 lesions receive study
treatment and 6 lesions receive placebo); each patient serves as his/her own control.
ARM I: Patients apply topical halofuginone hydrobromide ointment to each of 6 lesions twice
a day for 12 weeks.
ARM II: Patients apply topical placebo ointment to each of 6 lesions twice a day for 12
weeks.
Patients with stable or responding disease in either or both groups of treated lesions
(halofuginone hydrobromide ointment or placebo ointment) may receive open-label treatment
with topical halofuginone hydrobromide ointment to all 12 lesions for an additional 12 weeks
as above in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 1 month.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03596918 -
Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine
|
||
| Not yet recruiting |
NCT05567601 -
Doxil/Caelyx BE Study
|
Phase 1 | |
| Terminated |
NCT04893018 -
NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
|
Phase 1 | |
| Terminated |
NCT00020683 -
A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
|
Phase 2 | |
| Completed |
NCT00003350 -
Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma
|
Phase 3 | |
| Not yet recruiting |
NCT05411237 -
Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma
|
Phase 3 | |
| Active, not recruiting |
NCT05510973 -
Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi
|
N/A | |
| Recruiting |
NCT05510908 -
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
|
||
| Withdrawn |
NCT02137564 -
Gamma Secretase Inhibitor PF-03084014 in Treating Patients With AIDS-Associated Kaposi Sarcoma
|
Phase 2 | |
| Completed |
NCT01016730 -
Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma
|
Phase 1 | |
| Withdrawn |
NCT00521092 -
Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma
|
Phase 2 | |
| Completed |
NCT01057121 -
Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma
|
Phase 1/Phase 2 |