MDACC Study Summary 2006-0093

Study Summary
No. 2006-0093:.......Lymphoma; Skin......Madeleine Duvic......Dermatology

Study Summary Title



Study Summary Number:	2006-0093

Study Title:	Phase II Trial of Doxorubicin HCL Liposome injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)

Physician

New Patient Referral



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

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

Phone:	713-792-4578 Contact us about clinical trials

General Information



Disease Group:	Lymphoma Skin	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Sixteen clinic visits thereafter, every 3 months for 5 years or until progression.

Treatment Agents:	Doxil Targretin®	Home Care:	n/a

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if Doxil® (doxorubicin hydrochloride [HCL] liposome) followed by Targretin® (bexarotene) can help to control CTCL. The safety of these drugs will also studied.

Study Objectives / Outcomes

Primary Objective: To determine the progression-free survival in patients with Cutaneous T-Cell Lymphoma (CTCL) treated by doxorubicin HCL liposome (Doxil®) followed by bexarotene (Targretin®).Secondary Objective: To determine the major response rate (CR + PR) of doxorubicin hydrochloride liposome followed by bexarotene in the treatment of CTCL

Study Status Information



Study Activation / Registration Date:	07/19/2006

IRB Review and Approval Date:	04/05/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	37

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) Patient >/= 18 years of age.

2) Cutaneous T-cell lymphoma: TNM stages IB, IIA, IIB-IV with biopsy documentation within six weeks before treatment. Repeat biopsies are not required within six weeks before treatment for patients with Sézary syndrome and objective evidence of circulating cells.

3) KPS >/= 60

4) Acceptable organ function: absolute neutrophil count >/= 1500 micro/liters, platelet count >/= 100,000 micro/liters, bilirubin </= 1.5x upper limit of normal, creatinine </=1.5x upper limit of normal, SGOT (AST) and SGPT (ALT) ,</= 2.5x upper limit of normal

5) MUGA or 2-d echocardiogram indicating an ejection fraction of >/= 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.

6) Patients previously treated with doxorubicin HCL liposome or epirubicin are eligible if the total cumulative dose does not exceed 300 mg/m^2 for doxorubicin HCL liposome or 540 mg/^2 for epirubicin.

7) Negative pregnancy test. Effective birth control measures.

8) Topical corticosteroids, with the exception of those with high potency (class 1), will be allowed for patients with erythroderma-Sézary syndrome (T4) and tumor stage (T3) with intense pruritus. Therapy with non-prescription emollients will also be allowed on study.

Exclusion Criteria:

1) Pregnant or lactating women

2) No acute intercurrent disease including active potentially life-threatening infection or heart disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.

3) History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL liposome or components of Doxil

4) No demonstrated resistance to prior treatment with Targretin®.

5) Patients using class 1 high potency topical therapy will not be allowed on to the study.

Links

Registration Number: NCT00255801
Study Information on Clinical Trials Registry (clinicaltrials.gov)