Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma - Full Text View

Sponsor:	BioCryst Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00098332

Purpose

RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: forodesine hydrochloride	Phase 1

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients With Refractory Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	November 2004
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma.
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity.

Patients are followed periodically.

PROJECTED ACCRUAL: Not specified.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed cutaneous T-cell lymphoma
- Refractory to prior treatment
- Stage IIA, IIB, III, IVA, or IVB disease
Measurable disease

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 3 months

Hematopoietic

Not specified

Hepatic

AST and/or ALT ≤ 3 times upper limit of normal
Hepatitis B and/or hepatitis C negative

Renal

Creatinine clearance ≥ 40 mL/min

Immunologic

Human T-cell lymphotrophic virus type I (HTLV-I) negative
HIV negative
No active serious infection not controlled by antibiotics

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known impaired absorption of the gastrointestinal tract
No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 21 days since prior chemotherapy and recovered

Endocrine therapy

Concurrent topical corticosteroids allowed provided patient remains on a stable dose

Radiotherapy

No concurrent radiotherapy

Surgery

Not specified

Other

More than 30 days since prior investigational agents and recovered
No concurrent tanning bed use
No other concurrent therapy for cutaneous T-cell lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098332

Locations

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Florida
Cancer and Blood Disease Center
Lecanto, Florida, United States, 34461
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

BioCryst Pharmaceuticals

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00098332 History of Changes
Other Study ID Numbers:	CDR0000405886, BIOCRYST-BCX1777-C-04-105
Study First Received:	December 7, 2004
Last Updated:	July 20, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma

recurrent mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 21, 2012