Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)
Tracking Information | |||||
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | February 7, 2012 | ||||
Start Date ICMJE | July 2004 | ||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ] Bone marrow samples used to look at response to therapy collected every 3 months until disease progression or different therapy started. Clinical efficacy assessed as objective response (major and partial response) for responding patients analyzed by the Kaplan-Meier method. |
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Original Primary Outcome Measures ICMJE |
Objective Response Rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] Bone marrow samples collected every 3 months until the disease gets worse or t a different therapy started. Blood and bone marrow samples used to look at response to therapy. Clinical efficacy assessed as objective response (major and partial response). Time to progression (duration of time elapsed from the date of initial treatment with Ontak to the date of relapse or disease progression) and duration of response (from beginning of response to the time of relapse) for responding patients analyzed by the Kaplan-Meier method. |
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Change History | Complete list of historical versions of study NCT00493129 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM) | ||||
Official Title ICMJE | ONTAK (Denileukin Diftitox) in Patients With Systemic Mastocytosis | ||||
Brief Summary | Primary Objective: 1. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients. Secondary Objectives:
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Detailed Description | Denileukin diftitox has been used for the treatment of a variety of disorders, in particular, malignant lymphoma, another blood-related disease. Denileukin diftitox is believed to be able to specifically attach to and kill malignant mast cells. Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have blood (around 2 teaspoons) and bone marrow samples collected. To collect a bone marrow sample, an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. These samples will be used for tests to confirm the diagnosis of the disease. Women who are able to have children must have a negative blood pregnancy test. If you are found to be eligible, you will receive denileukin diftitox as an injection by vein once a day for 5 days in a row. This will be repeated every 3 weeks (1 cycle). You will receive treatment on an outpatient basis. Treatment will continue as long as there is evidence that therapy is affecting the disease and is beneficial to you. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. During treatment you will have blood (around 1 teaspoon) collected twice during every 3-week period. You will also have bone marrow samples collected every 3 months during the treatment. After the end of treatment, blood and bone marrow samples will be collected every 3 months until the disease gets worse or you start a different therapy. The blood and bone marrow samples will be used to look at response to therapy. This is an investigational study. Denileukin diftitox has been approved by the FDA for the treatment of skin T-cell lymphoma and is commercially available. The use of denileukin diftitox in this study is investigational. You will be provided denileukin diftitox free of charge. Up to 25 participants will take part in this study. All be enrolled at M. D. Anderson. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Ontak (Denileukin Diftitox)
9 µg/kg by vein Days 1-5 of a 21 day cycle.
Other Name: Denileukin Diftitox |
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Study Arm (s) | Experimental: Ontak
Ontak administered intravenously on Days 1-5 at the dose of 9 µg/kg/day, with a rest period from Days 6-21.
Intervention: Drug: Ontak (Denileukin Diftitox) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 8 | ||||
Completion Date | August 2007 | ||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493129 | ||||
Other Study ID Numbers ICMJE | 2004-0142 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | February 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |