A Phase I/II Clinical Trial of Lenalidomide in Combination With Oral Cyclophosphamide in Patients With Previously Treated Hormone Refractory Prostate Cancer
I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of
lenalidomide administered in combination with oral cyclophosphamide.
I. To evaluate the objective prostate-specific antigen (PSA) response (50% decrease in PSA
levels sustained for at least 4 weeks) as defined by PSA working group criteria; or a
decrease in absolute PSA or a decrease in PSA velocity, increase in PSA doubling time,
duration of any responses.
II. To explore the anti-tumor activity of the combination of lenalidomide plus oral
cyclophosphamide in patients with previously treated hormone refractory prostate cancer.
III. To evaluate baseline and change of quality of life, particularly, bone pain and
analgesic consumption, of the patients on this combination chemotherapy.
I. To determine whether related cytokines and biomarkers (serum levels of tumor necrosis
factor-alpha, basic fibroblast growth factor, vascular endothelial growth factor [VEGF], T
cell inhibitory activity, phytohemagglutin [PHA] and interleukin [IL]-2, mononuclear cell
isolation, VEGF, basic fibroblast growth factor [bFGF], interleukin [IL]-6) can help predict
response to patients undergoing treatment with lenalidomide and cyclophosphamide.
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and cyclophosphamide
PO QD on days 1-28. Treatment repeats every 28 days for at least 4 courses in the absence of
disease progression or unacceptable toxicity. Treatment modifications may apply according to
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenalidomide administered in combination with oral cyclophosphamide (Phase I)
Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.
University of Nebraska
United States: Institutional Review Board
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Saint Francis Medical Center||Grand Island, Nebraska 68802|
|Omaha Veterans Administration Medical Center||Omaha, Nebraska 68105|