Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00539591
First received: October 2, 2007
Last updated: February 26, 2014
Last verified: January 2014
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Interventions: Drug: Peginterferon alpha-2b
Drug: Temozolomide
Drug: Recombinant interferon alpha-2b

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 29 patients were enrolled between May 9, 2008 and August 22, 2012. Of the 29 participants, 21 were enrolled at St. Jude Children's Research Hospital (SJCRH), 7 at MD Anderson, and 1 at Rady Children's Hospital. Twenty-three participants met stratum A eligibility, 2 met stratum B1 eligibility and 4 met stratum B2 eligibility.

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
Peginterferon Alpha-2b/Non-pegylated Interferon Alpha-2b

Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon alpha-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon alpha-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Temozolomide/Peginterferon Alpha-2b With Measureable Disease

Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease

Participants received 8 weekly doses of peginterferon alpha-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Tempozolomide/Peginterferon Alpha-2b Without Measureable Disea

Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease

Participants received 8 weekly doses of peginterferon alpha-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined.


Participant Flow:   Overall Study
    Peginterferon Alpha-2b/Non-pegylated Interferon Alpha-2b     Temozolomide/Peginterferon Alpha-2b With Measureable Disease     Tempozolomide/Peginterferon Alpha-2b Without Measureable Disea  
STARTED     23     2     4  
COMPLETED     18     0     1  
NOT COMPLETED     5     2     3  
Toxicity                 3                 0                 0  
Disease progression                 2                 2                 3  



  Baseline Characteristics
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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
Peginterferon Alpha-2b/Non-pegylated Interferon Alpha-2b

Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon alpha-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon alpha-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Temozolomide/Peginterferon Alpha-2b With Measureable Disease

Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease

Participants received 8 weekly doses of peginterferon alpha-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Tempozolomide/Peginterferon Alpha-2b Without Measureable Disea

Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease

Participants received 8 weekly doses of peginterferon alpha-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined.

Total Total of all reporting groups

Baseline Measures
    Peginterferon Alpha-2b/Non-pegylated Interferon Alpha-2b     Temozolomide/Peginterferon Alpha-2b With Measureable Disease     Tempozolomide/Peginterferon Alpha-2b Without Measureable Disea     Total  
Number of Participants  
[units: participants]
  23     2     4     29  
Age  
[units: years]
Median ( Full Range )
  10.3  
  ( 2.4 to 20.0 )  
  11.9  
  ( 3.96 to 19.89 )  
  18.4  
  ( 3.6 to 22.1 )  
  10.77  
  ( 2.4 to 22.1 )  
Gender  
[units: participants]
       
Female     15     0     1     16  
Male     8     2     3     13  



  Outcome Measures

1.  Primary:   Tumor Response Rate   [ Time Frame: 8 weeks ]

2.  Primary:   Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum B Patients   [ Time Frame: 52 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Primary:   Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients   [ Time Frame: 52 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
The study closed early due to poor accrual to stratum B1.  


Results Point of Contact:  
Name/Title: Fariba Navid, MD
Organization: St. Jude Children's Research Hospital
phone: 901-595-2573
e-mail: info@stjude.org


No publications provided


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00539591     History of Changes
Other Study ID Numbers: MEL06
Study First Received: October 2, 2007
Results First Received: September 10, 2013
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board