MDACC Study Summary 2003-0960 (Archived)

Study Summary
No. 2003-0960:.......Lymphoma......Madeleine Duvic......Internal Medical Specialties

Study Summary Title



Study Summary Number:	2003-0960

Study Title:	UVALDEX (Methoxsalen) Sterile Solution in Conjunction with the Uvar XTS Photopheresis System as an Interventional Therapy for the Treatment of CTCL (Mycosis Fungoides) in Patients with TMN Classification Stage IA, IB, IIA

Physician

New Patient Referral



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

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

Phone:	713-745-1113 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	Therakos, Inc.

Phase of Study:	N/A	Return Visit:	Monthly evaluations in clinic and the patient will receive one UVAR XTS Photopheresis System treatment cycle on two consecutive days, approximately every four weeks.

Treatment Agents:	Questionaire Collection Biopsy Imaging Uvadex	Home Care:	None

Treatment Loc:	outpatient

Estimated Length of Stay in Houston:	3 hours x 2 days a month.


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Unavailable

Study Status Information



Study Activation / Registration Date:	04/02/2004

IRB Review and Approval Date:	02/04/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	12

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:

Patients are to be equal to or greater than 40 kg body weight.

Patients must have adequate veins to provide intravenous access.

Women who are not pregnant, lactating, or of childbearing potential.

Patients must be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study.

Patients must not be on any other investigational device/drug treatment.

Patients with the diagnosis of Mycosis Fungoides (MF) including a skin biopsy consistent with MR (atypical epidermotrophic or folliculocentric T-cells).

Appropriate staging as IA, IB or IIA: T1 or T2 with measurable lesions. IA patients must show evidence of a minor blood abnormality by morphology or lab assessment. For IIA patients, clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.

Patients must be willing and able to discontinue concomitant medications for MF.

Patients must be refractory to at least one of the standard therapies used to treat Stage IA, IB or IIA CTCL such as oral steroids, high dose topical steroids, HN2, Bexarotene, PUVA therapy, electron beam radiation, biological response or oral methotrexate.

Patients must abstain from therapeutic sunbathing, tanning beds, etc. for the duration of the study.

Patients must be equal to or greater than 18 years of age.

Exclusion Criteria:

Patients who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB-IVB, ie. no pathological node or visceral involvement.

Patients who are unable to tolerate extracorporeal volume loss (e.g., severe cardiac disease defined as congestive heart failure, unstable angina, or recent mycardial infarction within the last 6 months or severe anemia defined as hemoglobin less than 9.0 or body weight less than 40 kg).

Patients with recent (within three months) deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL or creatinine clearance less than 30.

Patients with lipemic plasma greater than 500 ng/dL and triglycerides greater than 500 or uncontrolled diabetes.

Patients with a history of liver damage (2.5 x normal ALT, AST) or porphyria.

Patients with positive tests for HIV antibody, HCV antibody or Hepatitis B Surface Antigen.

Patients on oral prednisone therapy or full body or high potency topical steroids.

Women who are pregnant or nursing a child.

Patients with severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen.

Patients who exhibit idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.

Patients with previous exposure to photopheresis therapy.

Patients who use tanning beds or are receiving phototherapy.

Links

Registration Number: NCT00221039
Study Information on Clinical Trials Registry (clinicaltrials.gov)