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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098332
• Other study ID #: BIOCRYST-BCX1777-C-04-105
• Secondary ID: CDR0000405886
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2004
• Last updated: July 9, 2013
• Start date: November 2004
• Est. completion date: July 2011

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• forodesine hydrochloride

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham	Birmingham	Alabama
United States	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Cancer and Blood Disease Center	Lecanto	Florida
United States	Yale Cancer Center	New Haven	Connecticut
United States	Stanford Comprehensive Cancer Center - Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United States,