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 Center Durham, North Carolina  27710
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Yale Cancer Center New Haven, Connecticut  06520-8028
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115
Stanford Comprehensive Cancer Center - Stanford Stanford, California  94305
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham Birmingham, Alabama  35294
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Burke Pharmaceutical Research Hot Springs, Arkansas  71913
Cancer and Blood Disease Center Lecanto, Florida  34461