Trial Outcomes & Findings for GM-CSF in Treating Patients With Relapsed Prostate Cancer (NCT NCT00908141)
NCT ID: NCT00908141
Last Updated: 2013-08-23
Results Overview
The number of patients with PSA modulation defined as PSA decline of at least 50%
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
post treatment at 9 weeks
Results posted on
2013-08-23
Participant Flow
Patients recruited from local medical clinic from June 2006 to August 2010.
Participant milestones
| Measure |
Group A: Sargramostim (Days 1-14)
GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle
|
Group B:Sargramostim (3 x Week)
GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group A: Sargramostim (Days 1-14)
GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle
|
Group B:Sargramostim (3 x Week)
GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
GM-CSF in Treating Patients With Relapsed Prostate Cancer
Baseline characteristics by cohort
| Measure |
Group A: Sargramostim (Days 1-14)
n=8 Participants
GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle
|
Group B: Sargramostim (3 x Week)
n=9 Participants
GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post treatment at 9 weeksThe number of patients with PSA modulation defined as PSA decline of at least 50%
Outcome measures
| Measure |
Group A: Sargramostim (Days 1-14)
n=8 Participants
GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle
|
Group B: Sargramostim (3 x Week)
n=8 Participants
GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Response
|
2 participants
|
0 participants
|
Adverse Events
Group A: Sargramostim (Days 1-14)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group B: Sargramostim (3 x Week)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Sargramostim (Days 1-14)
n=8 participants at risk
GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle
|
Group B: Sargramostim (3 x Week)
n=9 participants at risk
GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously
|
|---|---|---|
|
Vascular disorders
Thrombosis
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Renal and urinary disorders
Ureteral obstruction
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
Other adverse events
| Measure |
Group A: Sargramostim (Days 1-14)
n=8 participants at risk
GROUP A:
Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle
|
Group B: Sargramostim (3 x Week)
n=9 participants at risk
GROUP B:
Sargramostim 250ug subcutaneously (s.c.) three times a week continuously
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Investigations
Creatinine, elevated
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
22.2%
2/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Investigations
Elevated SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Investigations
Elevated SGPT (ALT) (serum glutamic pyruvic transaminase)
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
General disorders
Fatigue
|
37.5%
3/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
22.2%
2/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
General disorders
Flu-like Symptoms
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Gastrointestinal disorders
GI symptoms of nausea, emesis, and diarrhea
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Investigations
Hemoglobin
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
22.2%
2/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Renal and urinary disorders
Hemoglobinuria
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
22.2%
2/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
33.3%
3/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Blood and lymphatic system disorders
Infection with normal ANC, intermittent
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Blood and lymphatic system disorders
Infection with unknown ANC(Absolute neutrophil count)
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
87.5%
7/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
88.9%
8/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Gastrointestinal disorders
Intermittent rectal hemorrhage
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
22.2%
2/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Mid-low back pain
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
General disorders
Pain (Back and Left arm)
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Pain Left buttock
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right knee
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Musculoskeletal and connective tissue disorders
Pain, sciatic (right)
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
25.0%
2/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
11.1%
1/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
|
Investigations
Weight loss
|
12.5%
1/8 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
0.00%
0/9 • All patients will be evaluable for toxicity from the time of their first treatment with sargramostim through follow up over an approximate three year period.
|
Additional Information
Robert Dreicer MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-445-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place