Trial Outcomes & Findings for Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer (NCT NCT00939510)

NCT ID: NCT00939510

Last Updated: 2013-01-31

Results Overview

Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: reevaluated for response every eight weeks
• Results posted on: 2013-01-31

Participant Flow

Patients were recruited from November 2005 to April 2009 from medical clinic

Participant milestones

Measure	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.
Overall Study STARTED	32
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Lenalidomide (Revlimid) and Sargramostim (GM-CSF) n=32 Participants 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.
Age Continuous	68.7 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: reevaluated for response every eight weeks

Population: All patients that received treatment.

Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.

Outcome measures

Measure	Lenalidomide (Revlimid) and Sargramostim (GM-CSF) n=31 Participants 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.
Number of Patients With a PSA Response PSA response	4 participants
Number of Patients With a PSA Response PSA no response	27 participants

PRIMARY outcome

Timeframe: every 8 weeks and at end of treatment

Population: 12 patients had RECIST-defined measurable disease. One patient came off study early for toxicity and therefore was not evaluable.

Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks

Outcome measures

Measure	Lenalidomide (Revlimid) and Sargramostim (GM-CSF) n=11 Participants 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.
RECIST-defined Measurable Disease Number of patients with progressive disease	5 participants
RECIST-defined Measurable Disease Number of patients with stable disease (SD)	4 participants
RECIST-defined Measurable Disease Number of patients with partial response (PR)	2 participants

SECONDARY outcome

Timeframe: every 28 days for first 3 cycles, end of study

Population: All patients that received treatment

The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.

Outcome measures

Measure	Lenalidomide (Revlimid) and Sargramostim (GM-CSF) n=31 Participants 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.
Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study	0 participants

Adverse Events

Lenalidomide (Revlimid) and Sargramostim (GM-CSF)

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lenalidomide (Revlimid) and Sargramostim (GM-CSF) n=31 participants at risk 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.
Cardiac disorders Deep Venous Thrombosis (DVT)/Embolism	3.2% 1/31 • Patients followed for adverse events while on study over a three year period.
Investigations Elevated Lactate dehydrogenase (LDH)	6.5% 2/31 • Patients followed for adverse events while on study over a three year period.
Blood and lymphatic system disorders Leukopenia	3.2% 1/31 • Patients followed for adverse events while on study over a three year period.
Blood and lymphatic system disorders Neutropenia	9.7% 3/31 • Patients followed for adverse events while on study over a three year period.

Other adverse events

Measure	Lenalidomide (Revlimid) and Sargramostim (GM-CSF) n=31 participants at risk 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.
Blood and lymphatic system disorders Anemia	48.4% 15/31 • Patients followed for adverse events while on study over a three year period.
Gastrointestinal disorders Constipation	32.3% 10/31 • Patients followed for adverse events while on study over a three year period.
Gastrointestinal disorders Diarrhea	29.0% 9/31 • Patients followed for adverse events while on study over a three year period.
Investigations Elevated Lactate dehydrogenase (LDH)	16.1% 5/31 • Patients followed for adverse events while on study over a three year period.
General disorders Fatigue	71.0% 22/31 • Patients followed for adverse events while on study over a three year period.
Metabolism and nutrition disorders Hypocalcemia	22.6% 7/31 • Patients followed for adverse events while on study over a three year period.
General disorders Injection site reactions	54.8% 17/31 • Patients followed for adverse events while on study over a three year period.
Blood and lymphatic system disorders Leukopenia	35.5% 11/31 • Patients followed for adverse events while on study over a three year period.
Investigations Lymphopenia	38.7% 12/31 • Patients followed for adverse events while on study over a three year period.
Gastrointestinal disorders Nausea/Vomiting	35.5% 11/31 • Patients followed for adverse events while on study over a three year period.
Cardiac disorders Neutropenia	38.7% 12/31 • Patients followed for adverse events while on study over a three year period.
Skin and subcutaneous tissue disorders Skin (dryness, rash, pruritus)	51.6% 16/31 • Patients followed for adverse events while on study over a three year period.
Nervous system disorders Taste Alterations	22.6% 7/31 • Patients followed for adverse events while on study over a three year period.
Blood and lymphatic system disorders Thrombocytopenia	54.8% 17/31 • Patients followed for adverse events while on study over a three year period.

Additional Information

Dr. Robert Dreicer

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Phone: 216-445-4623

Email: dreicer@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place