Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01093183|
Recruitment Status : Terminated (study sponsors withdrew support for the study drug.)
First Posted : March 25, 2010
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer||Drug: lenalidomide Drug: cyclophosphamide Other: laboratory biomarker analysis Other: questionnaire administration Other: quality-of-life assessment||Phase 1 Phase 2|
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, phytohemagglutinin [PHA] and interleukin [IL]-2, mononuclear cell isolation, VEGF, basic fibroblast growth factor [bFGF], 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 study.
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 response.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Trial of Lenalidomide in Combination With Oral Cyclophosphamide in Patients With Previously Treated Hormone Refractory Prostate Cancer|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2015|
Experimental: Treatment (lenalidomide and cyclophosphamide)
Patients receive lenalidomide PO 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 response.
Other: laboratory biomarker analysis
Other: questionnaire administration
Other: quality-of-life assessment
Other Name: quality of life assessment
- Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I) [ Time Frame: 28 days ]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.
- Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria [ Time Frame: 4 weeks ]
- Anti-tumor Activity as Assessed by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) [ Time Frame: Up to 4 months ]As measured by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1), in which CR is defined as disappearance of target lesions and a partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions. PD is defined as 20% increase over smallest sum on study (including baseline if that is smallest) and at least 5 mm increase or new lesions. SD is defined as not enough response to be PR and not enough progression to be PD.
- Proportion of Patients Achieving CR [ Time Frame: At 4 months ]
- Overall Survival [ Time Frame: Up to 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093183
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||James Schwarz||University of Nebraska|