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Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

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ClinicalTrials.gov Identifier: NCT01977677
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : July 3, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lawrence Recht, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Ependymoblastoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Medulloblastoma
Adult Mixed Glioma
Adult Oligodendroglial Tumors
Adult Pineoblastoma
Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
Interventions Radiation: radiation therapy
Drug: temozolomide
Drug: plerixafor
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 30
Recruitment Details A total of 30 patients were enrolled at one study center.
Pre-assignment Details A total of 32 subjects were screened. One was a screen failure, one withdrew consent prior to initiating the infusion. Twenty-nine subjects enrolled and completed the 28 day Plerixafor infusion. One subject enrolled but did not complete the infusion due to an unrelated adverse event.
Arm/Group Title Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Hide Arm/Group Description One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks. One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks. One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
Period Title: Overall Study
Started 3 6 21
Completed 3 6 20
Not Completed 0 0 1
Reason Not Completed
Unrelated Adverse Event             0             0             1
Arm/Group Title Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day Total
Hide Arm/Group Description One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks. One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks. One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 3 6 20 29
Hide Baseline Analysis Population Description
Only subjects who completed the 4 week infusion were included
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 20 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
3
  50.0%
15
  75.0%
20
  69.0%
>=65 years
1
  33.3%
3
  50.0%
5
  25.0%
9
  31.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 6 participants 20 participants 29 participants
64
(55 to 67)
62
(40 to 74)
60
(29 to 74)
60
(29 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 20 participants 29 participants
Female
2
  66.7%
2
  33.3%
5
  25.0%
9
  31.0%
Male
1
  33.3%
4
  66.7%
15
  75.0%
20
  69.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 20 participants 29 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   5.0%
1
   3.4%
Not Hispanic or Latino
3
 100.0%
6
 100.0%
19
  95.0%
28
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 20 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
4
  20.0%
5
  17.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  10.0%
2
   6.9%
White
3
 100.0%
5
  83.3%
14
  70.0%
22
  75.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 6 participants 20 participants 29 participants
3 6 20 29
1.Primary Outcome
Title Dose-limiting Toxicity
Hide Description Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)
Time Frame Up to 30 days post plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Hide Arm/Group Description:
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
Overall Number of Participants Analyzed 3 6 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation
Hide Description Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.
Time Frame 6 months from start of irradiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Hide Arm/Group Description:
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
Overall Number of Participants Analyzed 3 6 20
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
5
  83.3%
19
  95.0%
Time Frame Up to 30 days after Plerixafor Infusion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Hide Arm/Group Description One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks. One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks. One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
All-Cause Mortality
Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/6 (0.00%)      1/21 (4.76%)    
Hide Serious Adverse Events
Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/6 (0.00%)      3/21 (14.29%)    
Gastrointestinal disorders       
Abdominal Pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Disease Progression  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Pseudoprogression  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/21 (0.00%)  0
Hemorrhagic hepatic cyst  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders       
Encephalopathy  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escalation: Plerixafor 200 mcg/kg/Day Escalation: Plerixafor 400 mcg/kg/Day Expansion: Plerixafor 400 mcg/kg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      6/6 (100.00%)      21/21 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/21 (9.52%)  2
Cardiac disorders       
Supraventricular Tachycardia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Ear and labyrinth disorders       
Tinnitus  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Eye disorders       
Conjunctivitis  1  1/3 (33.33%)  1 3/6 (50.00%)  3 0/21 (0.00%)  0
Dry Eyes  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Eye Pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Floaters  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/21 (0.00%)  0
Watering Eyes  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  1  2/3 (66.67%)  2 2/6 (33.33%)  2 3/21 (14.29%)  3
Nausea  1  0/3 (0.00%)  0 3/6 (50.00%)  3 3/21 (14.29%)  3
Dyspepsia  1  1/3 (33.33%)  1 1/6 (16.67%)  1 1/21 (4.76%)  1
Abdominal Pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/21 (9.52%)  2
Gastroesophageal reflux disease  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal Pain  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Oral dysesthesia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
General disorders       
Fatigue  1  1/3 (33.33%)  1 1/6 (16.67%)  1 6/21 (28.57%)  6
Gait Disturbance  1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/21 (9.52%)  2
Pain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/21 (9.52%)  2
Fever  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Localized Edema  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Immune system disorders       
Allergic Reaction  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/21 (0.00%)  0
Enhanced immune response  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Infections and infestations       
Bone infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Thrush  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Skin Infection  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Upper respiratory tract infection  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Investigations       
Platelet count decreased  1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/21 (9.52%)  2
Cardiac Troponin 1 increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
INR increased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Lymphocyte count decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
White blood cell decreased  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Metabolism and nutrition disorders       
Hypokalemia  1  1/3 (33.33%)  1 0/6 (0.00%)  0 1/21 (4.76%)  1
Hyperkalemia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Hypocalcemia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders       
Headache  1  1/3 (33.33%)  1 2/6 (33.33%)  2 4/21 (19.05%)  4
Dizziness  1  0/3 (0.00%)  0 0/6 (0.00%)  0 4/21 (19.05%)  4
Parasthesia  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/21 (0.00%)  0
Seizure  1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/21 (9.52%)  2
Cognitive Disturbance  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Dysgeusia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Facial Muscle Weakness  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Memory Impairment  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Tremor  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Psychiatric disorders       
Insomnia  1  1/3 (33.33%)  1 4/6 (66.67%)  4 7/21 (33.33%)  7
Confusion  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Hallucinations  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Bad dreams  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Renal and urinary disorders       
Hematuria  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
allergic Rhinitis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders       
wart like growth  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/21 (0.00%)  0
Rash maculopapular  1  0/3 (0.00%)  0 1/6 (16.67%)  1 1/21 (4.76%)  1
Bullous Dermatitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Allergic dermatitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Rash Spots on head  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/21 (4.76%)  1
Vascular disorders       
Hot Flashes  1  1/3 (33.33%)  1 2/6 (33.33%)  2 5/21 (23.81%)  5
Hypertension  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/21 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lawrence Recht, MD, Professor of Neurology
Organization: Stanford University School of Medicine
Phone: 650-725-8630
EMail: lrecht@stanford.edu
Layout table for additonal information
Responsible Party: Lawrence Recht, Stanford University
ClinicalTrials.gov Identifier: NCT01977677    
Other Study ID Numbers: BRN0023
NCI-2013-02012 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRN0023 ( Other Identifier: Stanford University Hospitals and Clinics )
P30CA124435 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2013
First Posted: November 7, 2013
Results First Submitted: June 5, 2018
Results First Posted: July 3, 2018
Last Update Posted: October 23, 2018