Abstract | PURPOSE: PATIENTS AND METHODS: This was a randomized, parallel-group, phase II study. COL-3 was administered orally once daily at one of two doses (group A received 50 mg and group B received 100 mg) to patients with AIDS-related KS. Antiretroviral therapy was permitted but not required. Serial tumor assessments and plasma levels of MMPs were obtained. Study end points were progressive KS and recurrent dose-limiting toxicity. RESULTS: Seventy-five patients received COL-3: 37 in group A and 38 in group B. Fifty-seven patients (76%) had received prior KS therapy. Thirty-three patients (44%) had more than 50 KS lesions. The response rate in group A was 41%, which was significantly greater than the prespecified target rate of 20% (95% CI, 25% to 58%; P = .003); the response rate of group B was 29% (P = not significant). There were significant declines in MMP-2 and MMP-9 plasma levels from baseline to minimum value with treatment ( MMP-2, P < .001; MMP-9, P = .001). The most common adverse events were photosensitivity and rash. CONCLUSION:
COL-3, when administered as 50 mg/d, is both active and well tolerated in the treatment of AIDS-related KS. COL-3 is a promising agent for the treatment of this opportunistic neoplasm of AIDS.
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Authors | Bruce J Dezube, Susan E Krown, Jeannette Y Lee, Kenneth S Bauer, David M Aboulafia |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 24
Issue 9
Pg. 1389-94
(Mar 20 2006)
ISSN: 1527-7755 [Electronic] United States |
PMID | 16549833
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Tetracyclines
- tetracycline CMT-3
- Matrix Metalloproteinase 2
- Matrix Metalloproteinase 9
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Topics |
- Acquired Immunodeficiency Syndrome
(complications)
- Administration, Oral
- Adult
- Aged
- Disease Progression
- Female
- Humans
- Male
- Matrix Metalloproteinase 2
(blood)
- Matrix Metalloproteinase 9
(blood)
- Middle Aged
- Sarcoma, Kaposi
(drug therapy)
- Tetracyclines
(administration & dosage, therapeutic use)
- Treatment Outcome
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