NCT00061880

Brief Summary

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractory 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 Feb 2003

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

3 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

February 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 30, 2013

Status Verified

July 1, 2004

Enrollment Period

1.9 years

First QC Date

June 5, 2003

Last Update Submit

May 29, 2013

Conditions

Lymphoma

Keywords

recurrent cutaneous T-cell non-Hodgkin lymphomastage I 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 I 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 (CTCL) * Any stage except IA patch only * Previously treated according to 1 of the following: * Stage IA plaque, IB, or IIA: * At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light \[PUVA\] and systemic corticosteroids) * Stage IIB, III, or IV: * At least 1 prior systemic regimen (systemic corticosteroids and PUVA do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered one regimen * Measurable disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-3 Life expectancy * At least 3 months Hematopoietic * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) * ALT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN * No hepatitis B or C Renal * Creatinine clearance at least 45 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * Human T-cell leukemia virus type 1 (HTLV-1) negative * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other illness that would limit study participation * No active serious infection not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer antibody therapy * No concurrent anticancer immunotherapy * No concurrent anticancer gene therapy * No concurrent anticancer vaccine therapy * No concurrent anticancer angiogenesis inhibitors * No concurrent sargramostim (GM-CSF) * No concurrent filgrastim (G-CSF) during course 1 of therapy Chemotherapy * More than 21 days since prior chemotherapy unless fully recovered * No concurrent anticancer chemotherapy Endocrine therapy * See Disease Characteristics * More than 2 weeks since prior topical corticosteroids * No concurrent anticancer hormonal therapy Radiotherapy * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 2 weeks since prior antineoplastic therapy * More than 21 days since prior investigational agents unless fully recovered * No concurrent citrate-blood products within 30 minutes before or after study treatment * No concurrent anticancer matrix metalloprotease inhibitors * No other concurrent anti-CTCL therapy * No concurrent use of tanning beds * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

University of Texas - MD Anderson Cancer Center

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 Officials

  • Alex Shalaurov, MD, PhD

    Inveresk Research Group, Incorporated

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

February 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2008

Last Updated

May 30, 2013

Record last verified: 2004-07

Locations

US(3)