Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
This study has been completed.
Sponsor:
Robert Dreicer MD
Collaborator:
Information provided by (Responsible Party):
Robert Dreicer MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00939510
First received: July 14, 2009
Last updated: January 24, 2013
Last verified: January 2013
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Results First Received: April 26, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Prostate Cancer |
| Interventions: |
Biological: sargramostim Drug: lenalidomide Other: laboratory biomarker analysis |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Patients were recruited from November 2005 to April 2009 from medical clinic |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle. |
Participant Flow: Overall Study
| Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | |
|---|---|
| STARTED | 32 |
| COMPLETED | 31 |
| NOT COMPLETED | 1 |
| Withdrawal by Subject | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle. |
Baseline Measures
| Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | |
|---|---|
|
Number of Participants
[units: participants] |
32 |
|
Age
[units: years] Mean ± Standard Deviation |
68.7 ± 7.3 |
|
Gender
[units: participants] |
|
| Female | 0 |
| Male | 32 |
|
Ethnicity (NIH/OMB)
[units: participants] |
|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 3 |
|
Race (NIH/OMB)
[units: particpants] |
|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
|
Region of Enrollment
[units: participants] |
|
| United States | 32 |
Outcome Measures
| 1. Primary: | Number of Patients With a PSA Response [ Time Frame: reevaluated for response every eight weeks ] |
| 2. Primary: | RECIST-defined Measurable Disease [ Time Frame: every 8 weeks and at end of treatment ] |
| 3. Secondary: | Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study [ Time Frame: every 28 days for first 3 cycles, end of study ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Dr. Robert Dreicer
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-4623
e-mail: dreicer@ccf.org
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-4623
e-mail: dreicer@ccf.org
No publications provided
| Responsible Party: | Robert Dreicer MD, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00939510 History of Changes |
| Other Study ID Numbers: | CASE3805, P30CA043703, IRB# 8121, RV-PCA-PI-059 |
| Study First Received: | July 14, 2009 |
| Results First Received: | April 26, 2012 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |