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Trial record 49 of 831 for:    Texas Children's Hospital | ( Map: United States )

Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma (PEPI)

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ClinicalTrials.gov Identifier: NCT00578864
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : November 6, 2012
Last Update Posted : July 17, 2015
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Peter Zage, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroblastoma
Interventions Drug: Protracted Oral Etoposide
Drug: Adriamycin and Cyclophosphamide
Drug: IV Cisplatin and IV Bolus Etoposide
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description 2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Period Title: Overall Study
Started 7 6
Completed 6 [1] 6
Not Completed 1 0
Reason Not Completed
Death             1             0
[1]
died of complications of surgery after 2 cycles
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide Total
Hide Arm/Group Description 2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Month
Number Analyzed 7 participants 6 participants 13 participants
26.9
(17.7 to 130.8)
25.3
(8.4 to 34.3)
26.9
(8.4 to 130.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
4
  57.1%
4
  66.7%
8
  61.5%
Male
3
  42.9%
2
  33.3%
5
  38.5%
1.Primary Outcome
Title Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.
Hide Description [Not Specified]
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description:
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II Window With Protracted Etoposide, Phase II Window With Bolus Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.367
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.
Hide Description If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description:
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
number of survival
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description:
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
3 2
4.Secondary Outcome
Title Percentage of Patients Who Have Surgery After the Second Cycle of Induction Therapy
Hide Description the measure is the number of patients who have surgery after two cycles of induction
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description:
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II Window With Protracted Etoposide, Phase II Window With Bolus Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
Hide Description The first of the two events (relapse or death) was chosen to represent disease free survival
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description:
2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
2 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Hide Arm/Group Description 2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
All-Cause Mortality
Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase II Window With Protracted Etoposide Phase II Window With Bolus Etoposide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders     
ALC *  2/7 (28.57%)  9 0/6 (0.00%)  0
ANC *  7/7 (100.00%)  44 6/6 (100.00%)  45
Hemoglobin *  7/7 (100.00%)  47 6/6 (100.00%)  27
PLT *  7/7 (100.00%)  58 6/6 (100.00%)  56
WBC *  6/7 (85.71%)  28 6/6 (100.00%)  39
INR *  1/7 (14.29%)  2 0/6 (0.00%)  0
PTT *  1/7 (14.29%)  1 0/6 (0.00%)  0
Hemorrhage/bleeding abdomen *  1/7 (14.29%)  1 0/6 (0.00%)  0
Cardiac disorders     
Hypotension *  1/7 (14.29%)  1 1/6 (16.67%)  1
Hypoxia *  1/7 (14.29%)  1 0/6 (0.00%)  0
Ear and labyrinth disorders     
Hearing- monitoring program *  1/7 (14.29%)  1 1/6 (16.67%)  1
Gastrointestinal disorders     
Ascites, non-malignant *  2/7 (28.57%)  2 1/6 (16.67%)  1
Diarrhea *  2/7 (28.57%)  2 0/6 (0.00%)  0
Esophagitis *  1/7 (14.29%)  1 0/6 (0.00%)  0
Mucositis/stomatitis *  2/7 (28.57%)  2 5/6 (83.33%)  5
Oral Mucositis/stomatitis *  1/7 (14.29%)  1 1/6 (16.67%)  1
Vomitting *  1/7 (14.29%)  1 0/6 (0.00%)  0
General disorders     
Fever *  1/7 (14.29%)  1 0/6 (0.00%)  0
Pain *  1/7 (14.29%)  1 0/6 (0.00%)  0
Immune system disorders     
Allergic reaction to Caspofungin *  1/7 (14.29%)  1 0/6 (0.00%)  0
Infections and infestations     
Febrile Neutropenia *  7/7 (100.00%)  12 6/6 (100.00%)  10
Infection *  2/7 (28.57%)  3 1/6 (16.67%)  1
Infection w/ grade 3 neutropenia *  1/7 (14.29%)  1 0/6 (0.00%)  0
Infection w/ grade 4 neutropenia *  1/7 (14.29%)  2 1/6 (16.67%)  1
Infection w/Grade2 ANC *  1/7 (14.29%)  1 0/6 (0.00%)  0
Infection w/grade 3 ANC *  2/7 (28.57%)  3 2/6 (33.33%)  2
Infection w/grade 3/4 ANC *  1/7 (14.29%)  2 1/6 (16.67%)  1
Infection w/grade 4 ANC *  3/7 (42.86%)  3 5/6 (83.33%)  11
Infection w/normal ANC *  4/7 (57.14%)  6 2/6 (33.33%)  4
Infection w/unknown ANC (suspected yeast) *  0/7 (0.00%)  0 1/6 (16.67%)  1
Infection with Gr 3/4 neutropenia (candida) *  1/7 (14.29%)  1 0/6 (0.00%)  0
Syphillis *  1/7 (14.29%)  1 0/6 (0.00%)  0
edema-trunk *  0/7 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders     
ALT *  2/7 (28.57%)  4 2/6 (33.33%)  3
AST *  2/7 (28.57%)  4 3/6 (50.00%)  3
Acidosis *  1/7 (14.29%)  4 0/6 (0.00%)  0
Bicarbonate *  1/7 (14.29%)  1 0/6 (0.00%)  0
GGT *  5/7 (71.43%)  6 5/6 (83.33%)  7
Hemoglobin *  0/7 (0.00%)  0 1/6 (16.67%)  1
Hypercalcemia *  2/7 (28.57%)  2 1/6 (16.67%)  1
Hyperglycemia *  3/7 (42.86%)  4 0/6 (0.00%)  0
Hyperkalemia *  1/7 (14.29%)  2 3/6 (50.00%)  3
Hypoalbuminemia *  3/7 (42.86%)  4 1/6 (16.67%)  2
Hypoglycemia *  0/7 (0.00%)  0 2/6 (33.33%)  3
Hypokalemia *  5/7 (71.43%)  11 4/6 (66.67%)  7
Hypomagnesemia *  0/7 (0.00%)  0 1/6 (16.67%)  1
Hyponatremia *  3/7 (42.86%)  3 3/6 (50.00%)  3
Hypophosphatemia *  2/7 (28.57%)  2 4/6 (66.67%)  6
Sodium *  0/7 (0.00%)  0 1/6 (16.67%)  4
Nervous system disorders     
Somnolence/depressed lvl consc. *  0/7 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia *  3/7 (42.86%)  4 1/6 (16.67%)  1
Infection with normal ANC (parainfluenza) *  1/7 (14.29%)  1 0/6 (0.00%)  0
Pleural effusion *  2/7 (28.57%)  2 1/6 (16.67%)  1
Vessel Injury/hepatic splenic arteries *  1/7 (14.29%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash- dermatitis assoc XRT (foot) *  0/7 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter Zage, MD
Organization: BAYLOR
Phone: 832-824-4615
Responsible Party: Peter Zage, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00578864     History of Changes
Obsolete Identifiers: NCT00600132
Other Study ID Numbers: H20255
PEPI ( Other Identifier: BCM )
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: October 5, 2012
Results First Posted: November 6, 2012
Last Update Posted: July 17, 2015