NCT00064142

A Phase II Trial of Topical Halofuginone in Patients With HIV Related Kaposi's Sarcoma

Completed Phase 2 Last updated 4 June 2013

What this trial tests

Phase 2 trial testing halofuginone hydrobromide in AIDS-related Kaposi Sarcoma in 30 participants. Completed.

Timeline

1 May 2003

Primary endpoint
1 December 2006

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 May 2003
Primary completion	1 December 2006
Sites	1 location across United States

Drugs / interventions tested

• halofuginone hydrobromide — full drug profile →
• placebo
• laboratory biomarker analysis — full drug profile →
• pharmacological study — full drug profile →

Conditions studied

• AIDS-related Kaposi Sarcoma — all drugs for AIDS-related Kaposi Sarcoma →
• Recurrent Kaposi Sarcoma — all drugs for Recurrent Kaposi Sarcoma →

Sponsor

National Cancer Institute (NCI)

Who can join

16 and older, any sex, with AIDS-related Kaposi Sarcoma or Recurrent Kaposi Sarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response rate
  Time frame: Up to 30 days
  McNemar's chi-square test will be used to compare vehicle control and halofuginone with respect to response rates.
• Safety of topical halofuginone as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
  Time frame: Up to 30 days after completion of treatment
  McNemar's chi-square test will be used to compare the two treatments with respect to the incidence of specific adverse events.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Initial steps of metastasis: cell invasion and endothelial transmigration.
   van Zijl F, Krupitza G, Mikulits W. · · 2011 · cited 597× · PMID 21605699 · DOI 10.1016/j.mrrev.2011.05.002
2. The role of collagen in cancer: from bench to bedside.
   Xu S, Xu H, Wang W, Li S, et al · · 2019 · cited 545× · PMID 31521169 · DOI 10.1186/s12967-019-2058-1
3. Natural Nrf2 Inhibitors: A Review of Their Potential for Cancer Treatment.
   Zhang J, Xu HX, Zhu JQ, Dou YX, et al · · 2023 · cited 49× · PMID 37416770 · DOI 10.7150/ijbs.82401
4. The integrated stress response in cancer progression: a force for plasticity and resistance.
   Lines CL, McGrath MJ, Dorwart T, Conn CS. · · 2023 · cited 46× · PMID 37601686 · DOI 10.3389/fonc.2023.1206561
5. Translation Regulation of the Glutamyl-prolyl-tRNA Synthetase Gene EPRS through Bypass of Upstream Open Reading Frames with Noncanonical Initiation Codons.
   Young SK, Baird TD, Wek RC. · · 2016 · cited 32× · PMID 27002157 · DOI 10.1074/jbc.m116.722256
6. Multiple aspects of matrix stiffness in cancer progression.
   Mancini A, Gentile MT, Pentimalli F, Cortellino S, et al · · 2024 · cited 30× · PMID 39015505 · DOI 10.3389/fonc.2024.1406644
7. Cancer-associated fibroblasts: protagonists of the tumor microenvironment in gastric cancer.
   Ozmen E, Demir TD, Ozcan G. · · 2024 · cited 30× · PMID 38562556 · DOI 10.3389/fmolb.2024.1340124
8. Control of fibrosis with enhanced safety via asymmetric inhibition of prolyl-tRNA synthetase 1.
   Yoon I, Kim S, Cho M, You KA, et al · · 2023 · cited 19× · PMID 37212275 · DOI 10.15252/emmm.202216940