Trial Outcomes & Findings for Immunotherapy of the Paraneoplastic Syndromes (NCT NCT00378326)
NCT ID: NCT00378326
Last Updated: 2023-09-18
Results Overview
Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
through study completion, median 3 years of follow up
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
Tacrolimus
Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunotherapy of the Paraneoplastic Syndromes
Baseline characteristics by cohort
| Measure |
Tacrolimus
n=26 Participants
Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
|
|---|---|
|
Age, Continuous
|
59.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: through study completion, median 3 years of follow upSurvival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment
Outcome measures
| Measure |
Pre-treatment
n=26 Participants
White blood cell (WBC) count in CSF pre-treatment
|
Post-treatment
White blood cell (WBC) count in CSF post-treatment
|
|---|---|---|
|
Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus
|
48 months
Interval 22.0 to 72.0
|
—
|
SECONDARY outcome
Timeframe: White blood cell count in CSF was measured at two time points, pre- and post-treatmentPopulation: 19 treatment events in 16 patients at which both pre- and post-treatment CSF samples available. The data are reported below, separately for pre-treatment samples and post-treatment samples.
Outcome measures
| Measure |
Pre-treatment
n=19 Treatment events
White blood cell (WBC) count in CSF pre-treatment
|
Post-treatment
n=19 Treatment events
White blood cell (WBC) count in CSF post-treatment
|
|---|---|---|
|
Cerebrospinal Fluid (CSF) Pleocytosis
|
3 cells/mm^3
Interval 0.0 to 51.0
|
3 cells/mm^3
Interval 0.0 to 41.0
|
Adverse Events
All Patients
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=26 participants at risk
All patients enrolled
|
|---|---|
|
Surgical and medical procedures
Hospitalization, search for primary tumor
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Ataxia and weakness
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
All Patients
n=26 participants at risk
All patients enrolled
|
|---|---|
|
General disorders
Albumin, serum low
|
11.5%
3/26 • Number of events 3
|
|
General disorders
ALT, serum high
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
3.8%
1/26 • Number of events 1
|
|
General disorders
AST, serum high
|
3.8%
1/26 • Number of events 1
|
|
General disorders
BUN, serum high
|
15.4%
4/26 • Number of events 6
|
|
General disorders
calcium, serum low
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
constipation
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
7.7%
2/26 • Number of events 2
|
|
General disorders
dizziness
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
swallowing difficulty
|
3.8%
1/26 • Number of events 1
|
|
General disorders
glucose, serum high
|
19.2%
5/26 • Number of events 6
|
|
Blood and lymphatic system disorders
HCT, low
|
11.5%
3/26 • Number of events 3
|
|
General disorders
headache
|
11.5%
3/26 • Number of events 3
|
|
Blood and lymphatic system disorders
hgb, low
|
15.4%
4/26 • Number of events 4
|
|
Nervous system disorders
dysarthria
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
tremor
|
11.5%
3/26 • Number of events 5
|
|
General disorders
insomnia
|
3.8%
1/26 • Number of events 1
|
|
General disorders
hot flashes
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
lymphocytes, low
|
3.8%
1/26 • Number of events 1
|
|
General disorders
depression
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
neutrophils, high
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
numbness/tingling
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
platelets, low
|
3.8%
1/26 • Number of events 1
|
|
General disorders
potassium, serum high
|
3.8%
1/26 • Number of events 1
|
|
General disorders
potassium, serum low
|
7.7%
2/26 • Number of events 2
|
|
General disorders
PTT, high
|
7.7%
2/26 • Number of events 2
|
|
Blood and lymphatic system disorders
RBC low
|
15.4%
4/26 • Number of events 4
|
|
General disorders
blurred vision
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
3.8%
1/26 • Number of events 1
|
|
Blood and lymphatic system disorders
WBC high
|
7.7%
2/26 • Number of events 2
|
|
Blood and lymphatic system disorders
WBC, low
|
11.5%
3/26 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place