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Rhodamine-123: therapy for hormone refractory prostate cancer, a phase I clinical trial
L W Jones1, K S Narayan, C E Shapiro
1Prostate Research Program, Huntington Medical Research Institutes, Pasadena, California 91101, USA. joneslw@hmri.org
Journal of Chemotherapy (Florence, Italy)
|September 20, 2005
Summary
Rhodamine-123 is a safe cancer drug for men with prostate cancer. It is retained in tumor tissue and can be given monthly without buildup in the body.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Rhodamine-123, a rhodocyanine dye, exhibits selective toxicity against carcinomas in vitro and in vivo.
- Prostate cancer, particularly hormone-refractory forms, presents a significant therapeutic challenge.
Purpose of the Study:
- To establish the safety and pharmacokinetics of Rhodamine-123 in patients with hormone-refractory prostate cancer.
- To determine the maximum tolerated dose (MTD) and assess safety during repeated administrations.
Main Methods:
- Phase I clinical trial involving men with hormone-refractory prostate cancer.
- Single and multiple dose toxicity studies to establish MTD and assess safety.
- Pharmacokinetic analyses of serum and assessment of drug retention in prostatic tissue.
Main Results:
- The maximum tolerated dose (MTD) of Rhodamine-123 was determined to be 96 mg/m2.
- Transient toxicities were observed but resolved within 6 hours post-infusion.
- No detectable drug accumulation in serum occurred with repeated monthly administrations; drug retention in prostatic tissue was confirmed.
- Variable lengthening of PSA doubling times suggested potential efficacy, though not statistically significant.
Conclusions:
- Rhodamine-123 can be safely administered monthly to men with hormone-refractory prostate cancer at the MTD of 96 mg/m2.
- The drug is retained in prostatic tumor tissue and does not accumulate in serum with repeated dosing.
- Further investigation into the efficacy of Rhodamine-123 for prostate cancer is warranted.
