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• W2591031736 abstract "4606 Background: We previously reported the safety of combining IFN α2b (IFN) with low dose (15 mg/m2 TIW) liposome-encapsulated all-trans retinoic acid (ATRA-IV) in patients (pts) with renal cancer (RC) (Cancer 2002;95:1220). ATRA-IV possesses increased and prolonged serum retinoid levels compared to oral ATRA. We conducted a phase I/II trial of higher-dose weekly ATRA-IV in combination with IFN in pts with advanced RC. Methods: Pts had histologically confirmed advanced RC, measurable disease and a KPS of ≥60%. In the phase I study, cohorts of 3–6 pts were treated with weekly ATRA-IV (dose levels: 60, 75, and 90 mg/m2) and IFN (3 million units (MU), escalated weekly to 5 and 7 MU, Mon-Fri) to establish any dose limiting toxicity (DLT) and the maximum tolerated dose (MTD). Ten pts have been treated on the phase II trial. Pts completing 8 weeks of therapy were evaluable for response. Serum RA pharmacokinetics were determined using high-performance liquid chromatography (HPLC) on weeks 1 and 8 and peripheral blood lymphocytes (PBMCs) were obtained to measure changes in gene expression. Results: Toxicity: 1 of 6 pts treated at the 75 mg/m2 dose level experienced Grade 3 leukopenia, requiring cessation of treatment. Three pts were treated at the 90 mg/m2 dose level without a DLT establishing ATRA-IV at 90 mg/m2 as the MTD. To date, no pt from the phase II arm has experienced any Grade 3/4 toxicity. Response: In 20 pts evaluable for response, 5 (25%) have demonstrated a major response (1 complete response in a pt with lung-only metastases and 4 partial responses). 5 additional pts (25%) have experienced stable disease, lasting 16+, 12, 10, 9+, and 2+ months. HPLC analysis demonstrate no significant difference between weeks 1 and 8 in serum RA pharmacokinetics. Correlative studies on PBMCs are in progress. Conclusions: The combination of ATRA-IV administered once a week with IFN is well tolerated and possesses anti-tumor activity in pts with advanced RC. The sustained increased serum RA concentrations support use of the liposomal delivery system. We are currently evaluating whether in vivo expression of RA inducible genes, including retinoic acid receptor RARβ, correlates with clinical response. No significant financial relationships to disclose." @default.
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• W2591031736 date "2005-06-01" @default.
• W2591031736 modified "2023-09-27" @default.
• W2591031736 title "Phase I/II trial of interferon α2b and ATRA-IV in the treatment of patients with advanced renal cancer" @default.
• W2591031736 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.4606" @default.
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