MDACC Study Summary 2007-0362

Study Summary
No. 2007-0362:.......Lymphoma; Skin......Madeleine Duvic......Dermatology

Study Summary Title



Study Summary Number:	2007-0362

Study Title:	An open label seven month study to evaluate the safety and efficacy of nitrogen mustard (NM) 0.04% ointment formulation in patients with stage I or IIA mycosis fungoides (MF) who have completed an initial 12 month treatment with nitrogen mustard 0.02% but without a complete response.

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:	Yaupon Therapeutics, Inc.

Phase of Study:	Phase II	Return Visit:	Every 2 months for 7 months and thereafter, every 2 months after completion of month 7

Treatment Agents:	Nitrogen Mustard	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a

Description/
Intervention:

The goal of this clinical research extension study is learn how well nitrogen
mustard (NM) 0.04% can control MF in patients who have been treated for 12
months with nitrogen mustard (NM) 0.02% (PG & AP formulations) while on
protocol 2005-0795 ["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)"].

Study Objectives / Outcomes

Primary Objective:

To evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF previously treated with NM 0.02% in a PG or AP ointment who did not achieve a complete response.

Secondary Objective:

To evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in the above patients.

Study Status Information



Study Activation / Registration Date:	07/10/2007

IRB Review and Approval Date:	07/10/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	100

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 (Fox Chase Cancer or designated Center) utilizing the histologic criteria previously employed in clinical trials for MF and a diagnosic algorithm for defining early MF developed by the International Society for Cutaneous Lymphoma (original study criteria).

3) Stage I and IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, or topical carmustine.

4) Completion of the treatment phase of the Yaupon Therapeutics-sponsored Phase II Pivotal study of NM 0.02% in either the PG or AP formulation without achieving a complete response. CAILS score must be greater than zero (0).

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

6) Must be free of serious concurrent illness (safety issue criteria).

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

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

Exclusion Criteria:

1) Newly diagnosed MF with no prior therapy (original study criteria).

2) A prior history of treatment with topical carmustine (BCNU).

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

4) Patients with a diagnosis of stage IIB - IV MF (original study criteria).

5) Patients who have a history of a higher T score than T2 or a higher N score than N1 (original study criteria).

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

7) Any patient who does not agree to do all lab studies at one site (original study criteria).

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

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 (original study criteria).

Links

Registration Number: NCT00535470
Study Information on Clinical Trials Registry (clinicaltrials.gov)