Clinical trial NCT00098332: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-12-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Stanford
country: United States
facility: Stanford Comprehensive Cancer Center - Stanford
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Lecanto
country: United States
facility: Cancer and Blood Disease Center
state: Florida
city: Boston
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center
state: Massachusetts
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: Charles M. Barrett Cancer Center at University Hospital
state: Ohio
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
Study officials:
References: