MDACC Study Summary 2005-0795

Study Summary
No. 2005-0795:.......Lymphoma; Skin......Madeleine Duvic......Dermatology

Study Summary Title



Study Summary Number:	2005-0795

Study Title:	A PHASE II PIVOTAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF NITROGEN MUSTARD (NM) 0.02% OINTMENT FORMULATIONS IN PATIENTS WITH STAGE I OR IIA MYCOSIS FUNGOIDES (MF)

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:	713-563-4655 Contact us about clinical trials

General Information



Disease Group:	Lymphoma Skin	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	11 visits for 12 months; Extended Toxicity Evaluation Period is every 3 months up to 12 months

Treatment Agents:	Nitrogen Mustard	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 compare the safety and effectiveness of 2 different formulations of a chemotherapy drug called nitrogen mustard for treating MF.

Study Objectives / Outcomes

Primary: To evaluate the efficacy of topical application of NM 0.02% in a propylene glycol ointment (PG) vs. NM 0.02% in an Aquaphor ointment (AP) in patients with stage I or IIA Mycosis Fungoides (MF).

Secondary: To evaluate the tolerability and safety of topical application of NM 0.02% ointment formulations in patients with stage I or II MF.

Study Status Information



Study Activation / Registration Date:	06/20/2006

IRB Review and Approval Date:	11/16/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	250

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) A diagnosis of stage I or IIA (cutaneous only) mycosis fungoides confirmed by a skin biopsy. Patients must not have used steroids for at least four (4) weeks before the diagnostic skin biopsy.

2) Diagnostic skin biopsies of MF as determined by both the local site dermatopathologist and the dermatopathologist at the lead site utilizing the histologic criteria previously employed in clinical trials for MF and a diagnosic algothrithm for defining early MF developed by the International Society for Cutaneous Lymphoma.

3) Stage I and IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM (within the last two years), or topical carmustine.

4) Laboratory values within the range of normal for the participating institution unless the principal investigator feels they are not clinically relevant (inclusion criteria 4 & 5).

5) CBC normal values: RBC (4.50 – 6.00 M/ul), WBC (4.0-11.0 M/ul), platelets 40- 440 K/ul, hematocrit (male 40.0 – 54.00%; female 37.0 -47.0%), hemoglobin (male 14.0 – 18.0g/dl; female 12.0 -16.0 g/dl). RBC morphology: MCH 27.0 – 47.0 pg, MCV 82-98 fl, MCHC 31.0-36.0 gm/dl, RDW 12.0 – 15.5%. WBC differential (neutrophils 1.7 – 7.3 K/ul, lymphocytes 1.0-4.8 K/ul, monocytes .08-.70 K/ul, eosinophils .04 -.40 K/ul, basophils 0 -.1 K/ul.

6) Serum chemistry normal values: sodium 135-47 mEq/L, CO2 24-30 mEq;L, potassium 3.5-5.0 mEq/L, BUN 8-20 mg/dL, creatinine .8 -1.5 mg/dL, glucose 70-110 mg/dL, SGOT(AST) 15-46 IU/L, SGPT(ALT) 7-56 IU/L, alkaline phosphatase 38-126 IU/L, t. bilirubin 0-1.0 mg/dL, lactic dehydrogenase 313-618 IU/L.

7) Must be willing and able to give informed consent, comply with study instructions and commit to all study visits and procedures.

8) Males and females of childbearing potential should be using an effective means of contraception.

Exclusion Criteria:

1) Newly diagnosed MF with no prior therapy.

2) Patients who have been treated with topical NM within the last two years or previously treated with topical carmustine (BCNU).

3) Use of topical or systemic therapies for MF within four (4) weeks of entry in the study.

4) Patients with a diagnosis of stage IIB – IV MF.

5) Patients who have a history of a higher T score of T2 or a higher N score of N1.

6) Patients who have had radiation therapy within one year of study start.

7) Any patient who does not agree to do all lab studies at one site

8) Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception.

9) Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program.

Links

Registration Number: NCT00168064
Study Information on Clinical Trials Registry (clinicaltrials.gov)