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Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans
Phase 2
Waitlist Available
Led By Scott Schuetze, MD, PhD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to and after 2-weeks of imatinib therapy
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.
Eligible Conditions
- Skin Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to and after 2-weeks of imatinib therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to and after 2-weeks of imatinib therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.
Side effects data
From 2013 Phase 1 & 2 trial • 14 Patients • NCT0128186575%
Anemia
75%
Hyperglycemia
75%
Platelet count decreased
67%
Hypertriglyceridemia
67%
White blood cell decreased
67%
Hypophosphatemia
58%
Aspartate aminotransferase increased
58%
Cholesterol high
42%
Fatigue
42%
Hypokalemia
42%
Alanine aminotransferase increased
33%
Hypoalbuminemia
33%
Lymphocyte count decreased
33%
Mucositis-oral
33%
Alkaline phosphatase increased
25%
Diarrhea
25%
Creatinine increased
25%
Neutrophil count decreased
25%
Rash maculo-papular
17%
Hypernatremia
17%
Blood bilirubin increased
17%
Hypocalcemia
17%
Nausea
8%
Intra-abdominal hemorrhage
8%
Constipation
8%
Dyspnea
8%
Papulopustular rash
8%
Peripheral sensory neuropathy
8%
Pneumonitis
8%
Tumor pain
8%
Anorexia
8%
Cough
8%
Hyponatremia
8%
Skin and subcutaneous tissue disorders Other, specify-dry split fingernails
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: imatinib mesylateExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
FDA approved
Find a Location
Who is running the clinical trial?
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,936 Total Patients Enrolled
Scott Schuetze, MD, PhDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
499 Total Patients Enrolled