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

July 9, 2013 updated by: BioCryst Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Lymphoma

Intervention / Treatment

Drug: forodesine hydrochloride

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.

Study Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

December 7, 2004

First Submitted That Met QC Criteria

December 7, 2004

First Posted (ESTIMATE)

December 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BIOCRYST-BCX1777-C-04-105
CDR0000405886 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.