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Trial record 17 of 524 for:    "Neuroblastoma"

Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide

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ClinicalTrials.gov Identifier: NCT01059071
Recruitment Status : Completed
First Posted : January 29, 2010
Results First Posted : June 20, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Cancer Prevention Pharmaceuticals, Inc.
University of Arizona
University of Hawaii
Information provided by (Responsible Party):
Giselle Sholler, Spectrum Health Hospitals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroblastoma
Interventions: Drug: DFMO
Drug: Etoposide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dose Level 1: 500 mg/m2 PO BID

DFMO: Escalating doses of DFMO in a 3 +3 cohort design.

DFMO at current cohort Dose Level orally each day for 21 day cycles

Dose level 1: 500 mg/m2 PO BID

Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.

Dose Level 2: 750 mg/m2 PO BID

DFMO: Escalating doses of DFMO in a 3 +3 cohort design.

DFMO at current cohort Dose Level orally each day for 21 day cycles

Dose level 2: 750 mg/m2 PO BID

Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.

Dose Level 3:1000 mg/m2 PO BID

DFMO: Escalating doses of DFMO in a 3 +3 cohort design.

DFMO at current cohort Dose Level orally each day for 21 day cycles

Dose level 3:1000 mg/m2 PO BID

Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.

Dose Level 4:1500 mg/m2 PO BID

DFMO: Escalating doses of DFMO in a 3 +3 cohort design.

DFMO at current cohort Dose Level orally each day for 21 day cycles

Dose level 4:1500 mg/m2 PO BID

Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.


Participant Flow:   Overall Study
    Dose Level 1: 500 mg/m2 PO BID   Dose Level 2: 750 mg/m2 PO BID   Dose Level 3:1000 mg/m2 PO BID   Dose Level 4:1500 mg/m2 PO BID
STARTED   4   5   3   9 
COMPLETED   2   1   1   3 
NOT COMPLETED   2   4   2   6 
Lack of Efficacy                1                4                2                3 
Withdrawal by Subject                1                0                0                2 
Physician Decision                0                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DFMO and Etoposide

DFMO: Escalating doses of DFMO in a 3 +3 cohort design.

DFMO at current cohort Dose Level orally each day for 21 day cycles

Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID

Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.


Baseline Measures
   DFMO and Etoposide 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Mean (Full Range)
 8.75 
 (1 to 17) 
Gender 
[Units: Participants]
 
Female   7 
Male   14 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   3 
Not Hispanic or Latino   16 
Unknown or Not Reported   2 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   17 
More than one race   0 
Unknown or Not Reported   2 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: length of study plus 30 days ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 2 years ]

3.  Secondary:   Number of Patients With an Overall Response Rate (ORR) of PR or CR   [ Time Frame: 1 year ]

4.  Secondary:   Tmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.   [ Time Frame: Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours ]

5.  Secondary:   Cmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.   [ Time Frame: Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours ]

6.  Secondary:   AUC of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.   [ Time Frame: Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Giselle Sholler, MD
Organization: NMTRC
phone: 6162670335
e-mail: giselle.sholler@helendevoschildrens.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Giselle Sholler, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT01059071     History of Changes
Other Study ID Numbers: NMTRC 002
First Submitted: January 26, 2010
First Posted: January 29, 2010
Results First Submitted: May 11, 2016
Results First Posted: June 20, 2016
Last Update Posted: October 27, 2016