Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
Phase II trial of pentosan polysulfate (PPS) in patients (pts) with AIDS-related Kaposi's sarcoma (KS) (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 12:A18 1993. Unique Identifier : AIDSLINE ICDB/93694418 Schwartsmann G; Sander E; Prolla G; Sprinz E; Zampese M; Vinholes J; Jung F; Kronfeld M; Kalakun L; Mans DA; et al; South-American Office for Anticancer Drug Development, Hospital; de Clinicas de Porto Alegre, Brazil
Abstract:
Basic fibroblast growth factor (b-FGF) is a protein which has been shown to stimulate angiogenesis. Inhibition of b-FGF was shown to block this phenomenon in several tumor models. KS is a highly angiogenic tumor which expresses in culture a protein (K-FGF) that acts in the same receptor as FGF. In this Phase II clinical trial in pts with AIDS-related KS, we evaluate the effect of PPS, a semisynthetic heparinoid which is capable of blocking b-FGF in the laboratory. PPS was administered as a sc injection bid daily at the dose of 25 mg/m2 until disease progression. Up to now 9 homosexual men were accrued. Median age was 34 yr (range 27-43). Median performance status (WHO) was 1 (range 0-2) all but 1 pt received concomitant AZT. All pts had disease progression. Five pts were Stage IVA, 2 pts were Stage IIIA and 2 pts were Stage IIIB according to the NYU criteria. All pts received PPS for a minimum of 15 days. A loading dose of 25 mg/m2 q 6 hr was given in the first day. Blood samples were collected for PPS pharmacokinetics and for functional tests immediately before drug administration and after 1, 4, 8, 12, 24 hr and daily up to day 7. No objective antitumor activity was observed so far. Six pts (67%) showed early progression (before day 21). Two pts showed stable disease during 40 days, while 1 pt was stable for 80 days. The main side effects of PPS were leukopenia (WHO grade I in 2 pts and grade II in 4 pts), thrombocytopenia (WHO grade I in one pt and Grade IV in one pt) and local pain (WHO grade I in one pt). No bleeding PT and/or PTT changes were observed. Blood samples for pharmacokinetics and functional studies are being processed. The trial is still open for accrual.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Adult Dose-Response Relationship, Drug Fibroblast Growth Factor, Basic/ANTAGONISTS & INHIB Human Male Pentosan Sulfuric Polyester/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Sarcoma, Kaposi's/*DRUG THERAPY Skin Neoplasms/*DRUG THERAPY ABSTRACT 931230
M93C0803
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Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
