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Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (ACTIVATe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643097
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : February 17, 2014
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
John Sampson, Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Neoplasms of Brain
Interventions Biological: PEP-3 vaccine
Biological: sargramostim
Drug: Temozolomide
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Hide Arm/Group Description Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death. Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle. Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
Period Title: Overall Study
Started 18 12 10
Completed 18 12 10
Not Completed 0 0 0
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI) Total
Hide Arm/Group Description Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death. Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle. Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle. Total of all reporting groups
Overall Number of Baseline Participants 18 12 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants 12 participants 10 participants 40 participants
52
(29 to 67)
57
(41 to 83)
59
(49 to 66)
53
(29 to 83)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 12 participants 10 participants 40 participants
Female
5
  27.8%
1
   8.3%
4
  40.0%
10
  25.0%
Male
13
  72.2%
11
  91.7%
6
  60.0%
30
  75.0%
1.Primary Outcome
Title Humoral and Cellular Immune Response
Hide Description Number of patients that developed a delayed-type hypersensitivity (DTH) response at following vaccination. Any skin reaction in response to the intradermal injection of the antigen was measured and recorded. A positive skin test was defined as > 5 mm induration (swelling).
Time Frame 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
The test was performed on a subset of patients in each group that were available at vaccine 8, and results posted for those 30 patients who had the tests performed.
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Hide Arm/Group Description:
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
Overall Number of Participants Analyzed 17 5 8
Measure Type: Number
Unit of Measure: participants
3 0 7
2.Primary Outcome
Title Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS)
Hide Description

Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).

Time Frame 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Hide Arm/Group Description:
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
Overall Number of Participants Analyzed 18 12 10
Median (95% Confidence Interval)
Unit of Measure: months
14.2
(9.9 to 17.6)
12.1
(10.5 to 23.7)
11.6
(8.1 to 12.7)
3.Secondary Outcome
Title Response to Vaccination
Hide Description The objective is to assess the duration of immunosuppressive cytokine secretion and to identify a receptive interval for active immunotherapy. Immunosuppression will determined by monitoring a panel of immunosuppressive serum/plasma cytokines longitudinally and by determining the response of each patient to Recombivax Hepatitis B (HB) vaccination. Response is defined as seropositive or seronegative to the Hepatitis B surface antigen.
Time Frame 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
This objective was not completed, as the test was not performed successfully.
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Hide Arm/Group Description:
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
Overall Number of Participants Analyzed 18 12 10
Mean (Standard Deviation)
Unit of Measure: Months
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
This objective was not completed, as the test was not performed successfully.
4.Secondary Outcome
Title Toxicity to PEP-3 Vaccine Immunization
Hide Description To assess for any potential toxicity to the PEP-3 vaccine immunization in patients with newly diagnosed glioblastoma, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to tabulate any toxicities attributable to PEP-3. The number of patients with toxicity attributable to vaccine while on study are tabulated.
Time Frame 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Hide Arm/Group Description:
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
Overall Number of Participants Analyzed 18 12 10
Measure Type: Number
Unit of Measure: participants
4 1 7
Time Frame 26 months
Adverse Event Reporting Description The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov.
 
Arm/Group Title Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Hide Arm/Group Description Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death. Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle. Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
All-Cause Mortality
Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   0/12 (0.00%)   3/10 (30.00%) 
Gastrointestinal disorders       
Dry mouth  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
General disorders       
Non-cardiac chest pain  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Immune system disorders       
Allergic reaction  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/18 (0.00%)  0/12 (0.00%)  2/10 (20.00%) 
Rash acneiform  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Rash maculo-papular  1  0/18 (0.00%)  0/12 (0.00%)  2/10 (20.00%) 
Vascular disorders       
Flushing  1  0/18 (0.00%)  0/12 (0.00%)  3/10 (30.00%) 
Hypotension  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (ACTIVATE) Arm II (ACT II STD) Arm III (ACT II DI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/18 (94.44%)   12/12 (100.00%)   9/10 (90.00%) 
Ear and labyrinth disorders       
Ear and labyrinth disorders - Other, specify: Ear Fullness - not infection  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Ear and labyrinth disorders - Other, specify: Left ear fluid  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
External ear inflammation  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Hearing impaired  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Tinnitus  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Endocrine disorders       
Hypothyroidism  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Eye disorders       
Blurred vision  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Eye disorders - Other, specify: Decreased Visual Acuity  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Eye disorders - Other, specify: Right Visual Field Cut  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Eye disorders - Other, specify: Visual Changes  1  2/18 (11.11%)  0/12 (0.00%)  0/10 (0.00%) 
Flashing lights  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/18 (0.00%)  3/12 (25.00%)  0/10 (0.00%) 
Constipation  1  0/18 (0.00%)  2/12 (16.67%)  2/10 (20.00%) 
Diarrhea  1  2/18 (11.11%)  0/12 (0.00%)  0/10 (0.00%) 
Dry mouth  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Dyspepsia  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Gastritis  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Gastrointestinal disorders - Other, specify: Eating while Asleep - side effect of medication  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Hemorrhoids  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Mucositis oral  1  0/18 (0.00%)  1/12 (8.33%)  1/10 (10.00%) 
Nausea  1  3/18 (16.67%)  6/12 (50.00%)  4/10 (40.00%) 
Rectal hemorrhage  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Vomiting  1  0/18 (0.00%)  2/12 (16.67%)  3/10 (30.00%) 
General disorders       
Chills  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Edema limbs  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Fatigue  1  9/18 (50.00%)  4/12 (33.33%)  4/10 (40.00%) 
Fever  1  2/18 (11.11%)  1/12 (8.33%)  1/10 (10.00%) 
Flu like symptoms  1  0/18 (0.00%)  0/12 (0.00%)  4/10 (40.00%) 
Gait disturbance  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
General disorders and administration site conditions - Other, specify: Drowsiness from medications  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Injection site reaction  1  1/18 (5.56%)  0/12 (0.00%)  2/10 (20.00%) 
Non-cardiac chest pain  1  0/18 (0.00%)  1/12 (8.33%)  1/10 (10.00%) 
Pain  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Immune system disorders       
Immune system disorders - Other, specify: Redness on opposite side of vaccine injection site  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Infections and infestations       
Abdominal infection  1  1/18 (5.56%)  1/12 (8.33%)  1/10 (10.00%) 
Bladder infection  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Bronchial infection  1  2/18 (11.11%)  1/12 (8.33%)  1/10 (10.00%) 
Conjunctivitis infective  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Infections and infestations - Other, specify: Epidermoid cyst in Head  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Infections and infestations - Other, specify: Ringworm  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Infections and infestations - Other, specify: Shingles  1  0/18 (0.00%)  2/12 (16.67%)  1/10 (10.00%) 
Lip infection  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Lung infection  1  2/18 (11.11%)  1/12 (8.33%)  0/10 (0.00%) 
Sinusitis  1  2/18 (11.11%)  0/12 (0.00%)  0/10 (0.00%) 
Skin infection  1  1/18 (5.56%)  1/12 (8.33%)  0/10 (0.00%) 
Upper respiratory infection  1  3/18 (16.67%)  2/12 (16.67%)  4/10 (40.00%) 
Injury, poisoning and procedural complications       
Postoperative hemorrhage  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Investigations       
Investigations - Other, specify: Vitamin D Deficiency  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Weight gain  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Weight loss  1  1/18 (5.56%)  0/12 (0.00%)  1/10 (10.00%) 
White blood cell decreased  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  3/18 (16.67%)  1/12 (8.33%)  1/10 (10.00%) 
Hypokalemia  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/18 (5.56%)  4/12 (33.33%)  2/10 (20.00%) 
Back pain  1  0/18 (0.00%)  2/12 (16.67%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify: Left-sided Abdominal Contractions  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify: Right Elbow Swelling/Bursitis  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Neck pain  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Pain in extremity  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Nervous system disorders       
Ataxia  1  2/18 (11.11%)  0/12 (0.00%)  2/10 (20.00%) 
Cerebrospinal fluid leakage  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Cognitive disturbance  1  0/18 (0.00%)  1/12 (8.33%)  1/10 (10.00%) 
Depressed level of consciousness  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Dizziness  1  5/18 (27.78%)  5/12 (41.67%)  2/10 (20.00%) 
Dysgeusia  1  0/18 (0.00%)  0/12 (0.00%)  2/10 (20.00%) 
Dysphasia  1  2/18 (11.11%)  0/12 (0.00%)  1/10 (10.00%) 
Headache  1  7/18 (38.89%)  2/12 (16.67%)  4/10 (40.00%) 
Hydrocephalus  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Memory impairment  1  1/18 (5.56%)  2/12 (16.67%)  1/10 (10.00%) 
Nystagmus  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Olfactory nerve disorder  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Peripheral motor neuropathy  1  3/18 (16.67%)  4/12 (33.33%)  2/10 (20.00%) 
Peripheral sensory neuropathy  1  2/18 (11.11%)  3/12 (25.00%)  3/10 (30.00%) 
Seizure  1  4/18 (22.22%)  1/12 (8.33%)  1/10 (10.00%) 
Syncope  1  3/18 (16.67%)  0/12 (0.00%)  0/10 (0.00%) 
Tremor  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Psychiatric disorders       
Agitation  1  1/18 (5.56%)  1/12 (8.33%)  3/10 (30.00%) 
Anxiety  1  0/18 (0.00%)  0/12 (0.00%)  2/10 (20.00%) 
Confusion  1  1/18 (5.56%)  0/12 (0.00%)  1/10 (10.00%) 
Depression  1  4/18 (22.22%)  1/12 (8.33%)  2/10 (20.00%) 
Insomnia  1  1/18 (5.56%)  0/12 (0.00%)  2/10 (20.00%) 
Libido decreased  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Renal and urinary disorders       
Urinary frequency  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Urinary incontinence  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Urinary retention  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  2/18 (11.11%)  2/12 (16.67%)  0/10 (0.00%) 
Cough  1  1/18 (5.56%)  1/12 (8.33%)  0/10 (0.00%) 
Dyspnea  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify: Cold symptoms  1  3/18 (16.67%)  2/12 (16.67%)  2/10 (20.00%) 
Voice alteration  1  0/18 (0.00%)  1/12 (8.33%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  1/18 (5.56%)  1/12 (8.33%)  1/10 (10.00%) 
Pruritus  1  1/18 (5.56%)  1/12 (8.33%)  1/10 (10.00%) 
Rash acneiform  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Rash maculo-papular  1  3/18 (16.67%)  5/12 (41.67%)  3/10 (30.00%) 
Vascular disorders       
Flushing  1  0/18 (0.00%)  0/12 (0.00%)  1/10 (10.00%) 
Hematoma  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Hypertension  1  1/18 (5.56%)  0/12 (0.00%)  1/10 (10.00%) 
Thromboembolic event  1  1/18 (5.56%)  0/12 (0.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. John H. Sampson
Organization: Duke University Medical Center
Phone: 919-684-9041
EMail: john.sampson@duke.edu
Layout table for additonal information
Responsible Party: John Sampson, Duke University
ClinicalTrials.gov Identifier: NCT00643097    
Obsolete Identifiers: NCT00090597
Other Study ID Numbers: Pro00004040
P50NS020023 ( U.S. NIH Grant/Contract )
CDR0000589632 ( Other Identifier: National Cancer Institute )
DUMC-5421 ( Registry Identifier: DUMC IRB )
First Submitted: March 25, 2008
First Posted: March 26, 2008
Results First Submitted: January 6, 2014
Results First Posted: February 17, 2014
Last Update Posted: February 1, 2017