Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans

NCT00243191 | Completed Phase 2 Results DMC

• 1 other identifier: SARC004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.

Conditions

Dermatofibrosarcoma Protuberans

Keywords

newly diagnosed or recurrent

Outcome Measures

Primary Outcomes (1)

• 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.

  To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.

  Prior to and after 2-weeks of imatinib therapy

Study Arms (1)

imatinib mesylate

OTHER

Drug: imatinib mesylate

Interventions

imatinib mesylate DRUG

400 mg orally twice a day for 10 - 14 days

Also known as: Gleevec

imatinib mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ or equal to 18 years of age.
• Suspected or documented diagnosis of dermatofibrosarcoma protuberans (DFSP). Patients with suspected diagnosis of DSFP must have DFSP confirmed by pathology at the local institution prior to dispensing and the start of imatinib.
• Patient is medically able to undergo surgical resection of the DFSP and resection of the DFSP is recommended for clinical management of the disease.
• Patient has at least one site of measurable (macroscopic) disease.
• Performance status 0, 1 or 2 Eastern Cooperative Oncology Group (ECOG) (see Section 7.1).
• Adequate end organ function, defined as the following:
• total bilirubin \< 1.5 x institutional upper limit of normal (ULN), SGOT and SGPT \< 2.5 x UNL, creatinine \< 1.5 x ULN, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L.
• Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
• Written, voluntary informed consent.

You may not qualify if:

• Patients who will receive radiation therapy to the site of DFSP prior to resection.
• Patients with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
• Female patients who are pregnant or breast-feeding.
• Patients who have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) that may worsen because of imatinib.
• Patients who have known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
• Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patients who have received chemotherapy within 4 weeks prior to study entry.
• Patients who have had a major surgery within 2 weeks prior to study entry. Incisional biopsy or partial excision of dermatofibrosarcoma protuberans to establish the diagnosis and/or to collect pretreatment tumor tissue does not qualify as major surgery.

Sponsors & Collaborators

• Sarcoma Alliance for Research through Collaboration: lead

Study Sites (4)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Pennsylvania Onc/Hem Assoc.

Philadelphia, Pennsylvania, 19106, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• SARC Website

MeSH Terms

Conditions

Dermatofibrosarcoma; Recurrence

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Dermatofibrosarcoma protuberans (DFSP)is a rare tumor type. During the the trial the drug manufacturer obtained approval for DSFP indication.The other limitation is limited funding; SARC is actively seeking funding for secondary outcome goal 12/2012.

Results Point of Contact

• Title: SARC, Chief Operating Officer
• Organization: SARC

sarc@sarctrials.org

734-930-7600

Study Officials

• Scott Schuetze, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: May 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 29, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-02

Locations

US (4)