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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

CDR0000405886

NCT ID:

NCT00098332

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Burke Pharmaceutical ResearchHot Springs, Arkansas  71913
Cancer and Blood Disease CenterLecanto, Florida  34461