Trial Outcomes & Findings for Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas (NCT NCT00590954)
NCT ID: NCT00590954
Last Updated: 2020-10-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
6 months
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
Treatment
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
|---|---|
|
Overall Study
Inevaluable
|
2
|
Baseline Characteristics
Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas
Baseline characteristics by cohort
| Measure |
Treatment
n=32 Participants
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Glioblastoma
n=16 Participants
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
Anaplastic Glioma
n=14 Participants
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
|---|---|---|
|
Determine the Efficacy of Perifosine in Patients With Recurrent/Progressive GBMs Not Taking EIAEDs as Measured by 6 Month Progression Free Survival/PFS.
|
1.58 months
Interval 1.08 to 1.84
|
2.12 months
Interval 1.84 to 12.79
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 22 serious events
Other events: 32 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Treatment
n=32 participants at risk
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
|---|---|
|
Psychiatric disorders
Confusion
|
6.2%
2/32 • 1 year
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
3.1%
1/32 • 1 year
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
9.4%
3/32 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.1%
1/32 • 1 year
|
|
General disorders
Extremity-lower (gait/walking)
|
12.5%
4/32 • 1 year
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.1%
1/32 • 1 year
|
|
General disorders
Fever (in the absence of neutropenia)
|
3.1%
1/32 • 1 year
|
|
Nervous system disorders
Hemorrhage, CNS
|
3.1%
1/32 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
3.1%
1/32 • 1 year
|
|
Infections and infestations
Inf unknown ANC-Pneumonia(lung)
|
3.1%
1/32 • 1 year
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Wound
|
3.1%
1/32 • 1 year
|
|
Nervous system disorders
Memory impairment
|
3.1%
1/32 • 1 year
|
|
Psychiatric disorders
Mood alteration - Agitation
|
3.1%
1/32 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Extremity-lower
|
3.1%
1/32 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Left-sided
|
12.5%
4/32 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Whole body/general
|
9.4%
3/32 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • 1 year
|
|
Nervous system disorders
Neurology - Other (specify)
|
9.4%
3/32 • 1 year
|
|
Nervous system disorders
Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx
|
3.1%
1/32 • 1 year
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
3.1%
1/32 • 1 year
|
|
Nervous system disorders
Pain - Head/headache
|
3.1%
1/32 • 1 year
|
|
General disorders
Pain - Pain NOS
|
3.1%
1/32 • 1 year
|
|
Gastrointestinal disorders
Pain - Stomach
|
3.1%
1/32 • 1 year
|
|
Investigations
Platelets
|
3.1%
1/32 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malig-poss related to ca txt specify
|
6.2%
2/32 • 1 year
|
|
Nervous system disorders
Seizure
|
40.6%
13/32 • 1 year
|
|
Nervous system disorders
Somnolence/dprssd level of conscious
|
9.4%
3/32 • 1 year
|
|
Nervous system disorders
Speech impairment
|
9.4%
3/32 • 1 year
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.2%
2/32 • 1 year
|
Other adverse events
| Measure |
Treatment
n=32 participants at risk
Following a diagnosis of tumor recurrence or progression, all patients will receive perifosine monotherapy until toxicity, progression, or death.
Perifosine: Dosing will be continuous, and for the purpose of this trial a cycle will be defined as 28 days. Perifosine will be given as a 600 mg loading dose on day 1. The loading dose will be divided into 4 equal doses of 150 mg each. The first 3 doses should be given with food in the adult day hospital to allow intravenous antiemetic prophylaxis, and 4th dose at bedtime at home. The interval between doses of perifosine should be no less than 4 hours. On day 2, patients will start the maintenance dose of 100 mg daily at bedtime at home.
In addition to baseline serum, all patients will have weekly serum drawn during weeks 2-4.
|
|---|---|
|
Investigations
Thrombocytopenia
|
28.1%
9/32 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
16/32 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.6%
5/32 • 1 year
|
|
Investigations
Lymphopenia
|
9.4%
3/32 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • 1 year
|
|
Investigations
Increased alanine aminotransferase
|
40.6%
13/32 • 1 year
|
|
General disorders
Fatigue
|
31.2%
10/32 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
21.9%
7/32 • 1 year
|
|
Investigations
Elevated aspartate transaminase (AST)
|
18.8%
6/32 • 1 year
|
|
Investigations
Leukopenia
|
15.6%
5/32 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
15.6%
5/32 • 1 year
|
|
Investigations
Alkaline phosphatase
|
9.4%
3/32 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
2/32 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.1%
1/32 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.1%
1/32 • 1 year
|
Additional Information
Thomas Kaley, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place