Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA
- Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase
II dose of absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) in
patients with nonmetastatic, hormone-refractory prostate cancer and rising serum
prostate-specific antigen (PSA) levels.
- Evaluate the toxicities of BR-DIM.
- Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in
this patient population.
- Evaluate the effect of BR-DIM supplementation on serum PSA level.
- Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in
patients taking BR-DIM supplementation.
- Determine quality of life measures in patients taking BR-DIM supplementation.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane
(BioResponse-DIM^® [BR-DIM]) twice daily on days 1-28. Treatment repeats every 28 days for
up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Quality of life is assessed at baseline, on day 1 of each course, and at the completion of
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose during study and for 30 days after
Elisabeth I. Heath, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Weisberg Cancer Treatment Center||Detroit, Michigan 48334|