MDACC Study Summary 2004-0655 (Archived)

Study Summary
No. 2004-0655:.......Lymphoma......Madeleine Duvic......Dermatology

Study Summary Title



Study Summary Number:	2004-0655

Study Title:	A Phase I/II, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients with Refractory Cutaneous T-Cell Lymphoma Protocol ID: BCX1777-C-04-105

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	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	12 visits at the completion of 28 days of treatment.

Treatment Agents:	Forodesine Hydrochloride	Home Care:	Patients will be taking oral Forodesine Hydrochloride in the morning before the first meal of the day

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this clinical research study is to find the highest safe dose of forodesine hydrochloride that can be given in the treatment of CTCL with the least number of side effects. Researchers want to find out if the study drug will work in reducing or stopping the growth of CTCL. There will also be quality of life evaluations to see how you feel while you are taking the study drug.

Study Objectives / Outcomes

Primary:

To determine the safety of oral Forodesine Hydrochloride in patients with refractory cutaneous T-cell lymphoma (CTCL)
To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of oral Forodesine Hydrochloride
To find the maximum tolerated dose (MTD) for forodesine hydrochloride in patients with Refractory Cutaneous T-Cell Lymphoma (up to a maximum daily dose of 320 mg/m²)

Secondary:

To correlate the plasma levels of oral Forodesine Hydrochloride with dGuo plasma levels
To assess any preliminary evidence of efficacy of oral Forodesine Hydrochloride
To assess the change in quality of life of patients treated with oral Forodesine Hydrochloride
To confirm that sufficient plasma dGuo and plasma drug levels are achieved with the new 100-mg,formulated capsule
To confirm the optimal dose group for this indication based on preliminary efficacy, PK/PD, and safety results

Study Status Information



Study Activation / Registration Date:	12/02/2004

IRB Review and Approval Date:	10/20/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	72

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) Men and non-pregnant, non-lactating women at least 18 years of age.

2) Previously treated, refractory CTCL, histologically proven with measurable disease greater than IB.

3) Performance status of less than or equal 2 by Eastern Cooperative Oncology Group (ECOG) criteria.

4) Adequate liver function: (aspartate transaminase (AST) and/or alanine transaminas (ALT) not greater than 3 times upper limits normal.

5) Adequate kidney function: calculated creatinine clearence greater or equal to 40 mL/min. Creatinine clearence will be calculated using the Cockroft-Gault formula: For males: (140-age) (lean body weight in kg)/ serum creatinine x 72 For females: (140-age) (lean body weight in kg) (0.85)/ serum creatinine x 72.

6) Negative pregnancy test within 14 days of study treatment in females of childbearing potential.

7) Female of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized.

8) Life expectancy of at least 3 months.

9) Signed informed consent form (ICF) prior to the start of any study-specific procedure.

Exclusion Criteria:

1) Active serious infection not controlled by antibiotics.

2) Treatment with any investigational agent(s ) within last 30 days or chemotherapy with approved agents in last 21 days and patients has not fully recovered from any side effects from either therapy.

3) Known impaired absorption from the gastrointestinal (GI) tract.

4) Concurrent treatment with other anti-CTCL therapy, tanning beds or radiation therapy. (Topical corticosteroid use will not be excluded, but the patient must be on and remain on a stable dose).

5) Patients with known HIV infection or human T-cell leukemia virus type 1 (HTLV-1). HIV testing will be performed at the screening visit for patients who have not been tested within 6 months of recieving study drug, as well as those patients who had exposure or have been transfused with blood products that were not appropriately screened.

6) Patients with known hepatitis B and /or hepatitis C active infection. Hepatitis testing will be performed at the screening visit for patients who have not been tested within 6 months of recieving study drug, as well as those patients who had exposure or have been transfused with blood products that were not appropriately screened.

7) Any other illness that would limit the ability to complete the study.

8) Hypersensitive or intolerant to any component of the study drug formulation

Links

Registration Number: NCT00098332
Study Information on Clinical Trials Registry (clinicaltrials.gov)