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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
forodesine hydrochloride
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  • Burke Pharmaceutical Research
  • Stanford Comprehensive Cancer Center - Stanford
  • University of Colorado Cancer Center at UC Health Sciences Center
  • Yale Cancer Center
  • Cancer and Blood Disease Center
  • Dana-Farber/Brigham and Women's Cancer Center
  • Duke Comprehensive Cancer Center
  • Charles M. Barrett Cancer Center at University Hospital
  • M.D. Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2004
Last Updated
July 9, 2013
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00098332
Brief Title
Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Stanford Comprehensive Cancer Center - Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Cancer and Blood Disease Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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