NCT00098332

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2004

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 10, 2013

Status Verified

June 1, 2007

Enrollment Period

6.1 years

First QC Date

December 7, 2004

Last Update Submit

July 9, 2013

Conditions

Lymphoma

Keywords

recurrent cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndrome

Interventions

forodesine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Stanford Comprehensive Cancer Center - Stanford

Stanford, California, 94305, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Cancer and Blood Disease Center

Lecanto, Florida, 34461, United States

Location

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02115, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45219, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

November 1, 2004

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

July 10, 2013

Record last verified: 2007-06

Locations

US(10)