MDACC Study Summary 2005-0618 (Archived)

Study Summary
No. 2005-0618:.......Sarcoma......Jonathan Trent......Sarcoma Medical Oncology

Study Summary Title



Study Summary Number:	2005-0618

Study Title:	Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans

Physician

New Patient Referral



Name:	Jonathan Trent	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Sarcoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3626 Contact us about clinical trials

General Information



Disease Group:	Sarcoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Screening visit and testing, weekly blood work, hospitalization for surgery and outpatient postoperative follow up visit.

Treatment Agents:	Imatinib Surgical Procedure	Home Care:	Patients will self administer preoperative imatinib at home.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Length of hospitalization stay will be determined by planned surgical procedure and expected postoperative recovery time.


Description/ Intervention:	The purpose of this clinical trial is entirely scientific. The objectives are to see how Gleevec (imatinib mesylate) may affect DFSP at the cellular or molecular level, and inhibit growth of the disease, cause tumor cells to die, or if DFSP can become resistant to Gleevec. This will help doctors understand the biology of DFSP.

Study Objectives / Outcomes

Primary: The purpose of this study is to determine whether imatinib mesylate affects autocrine / paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in dermatofibrosarcoma protuberans (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. This is not a treatment protocol.

Secondary:
a. To correlate inhibition of PDGFRB phosphorylation with plasma and tissue levels of imatinib.
b. To study the effects of imatinib on phosphorylation of effector molecules downstream of PDGFRB in a preliminary fashion.
c. To correlate inhibition of PDGFRB phosphorylation with inhibition of tumor proliferation.
d. To correlate inhibition of PDGFRB phosphorylation with induction of tumor cell apoptosis.
e. To bank matched tumor tissue before and after treatment with imatinib for future use in cDNA microarray and tissue array studies.

Study Status Information



Study Activation / Registration Date:	04/16/2007

IRB Review and Approval Date:	05/11/2006

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	20

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients greater than or equal to 18 years of age.

2) Suspected or documented diagnosis of dermatofibrosarcoma protuberans (DFSP). Patients with suspected diagnosis of DFSP must have DFSP confirmed by pathology at the local institution prior to dispensing and the start of imatinib.

3) Patient is medically able to undergo surgical resection of the DFSP and resection of the DFSP is recommended for clinical management of the disease.

4) Patient has at least one site of measurable (macroscopic) disease.

5) Performance status 0, 1 or 2 (ECOG).

6) 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 ULN, creatinine < 1.5 x ULN, absolute neutrophil count > 1.5 x 10^9/L, platelets > 100 x 10^9/L.

7) 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.

8) Written, voluntary informed consent.

Exclusion Criteria:

1) Patients who will receive radiation therapy to the site of DFSP prior to resection.

2) Patients with Grade III / IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure) or myocardial infarction within 6 months of study.

3) Female patients who are pregnant or breast feeding.

4) 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.

5) Patients who have known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).

6) Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection.

7) Patients who have received chemotherapy within 4 weeks prior to study entry.

8) 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.

Links

Registration Number: NCT00243191
Study Information on Clinical Trials Registry (clinicaltrials.gov)