Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
This study has been completed.
Sponsor:
BioCryst Pharmaceuticals
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098332
First received: December 7, 2004
Last updated: July 20, 2011
Last verified: June 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: forodesine hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | November 2004 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098332
Locations
| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Stanford Comprehensive Cancer Center - Stanford | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado Cancer Center at UC Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Florida | |
| Cancer and Blood Disease Center | |
| Lecanto, Florida, United States, 34461 | |
| United States, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
Sponsors and Collaborators
BioCryst Pharmaceuticals
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00098332 History of Changes |
| Other Study ID Numbers: | CDR0000405886, BIOCRYST-BCX1777-C-04-105 |
| Study First Received: | December 7, 2004 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 23, 2013