Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

Sponsor

BioCryst Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00095381

Collaborator

(none)

Enrollment

Locations

Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.

Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, T-Cell	Drug: forodesine hydrochloride (BCX-1777)	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL) []

Secondary Outcome Measures

Safety and tolerability []
Pharmacokinetics (PK) and Pharmacodynamics (PD) []
maintenance of response and safety in long-term treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
Failure to have responded to one or more standard regimens for their disease.
Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria
All ages are eligible
Life expectancy of at least 3 months
Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits or normal [ULN])
Adequate kidney function (calculated creatinine clearance >50 mL/min)
Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential
Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study
Signed informed consent/assent form (ICF) prior to start of any study specific procedures

Exclusion Criteria:

Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
Patients with known Hepatitis B and/or Hepatitis C active infection
Patients with active CMV infection
Tumor-related central nervous system (CNS) leukemia requiring active treatment
Active serious infection not controlled by oral or IV antibiotics
Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
Pregnant and/or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States	90024
2		Palo Alto	California	United States	94304
3		Denver	Colorado	United States	80262
4		Gainesville	Florida	United States	32611
5		Lecanto	Florida	United States	34461
6		Atlanta	Georgia	United States	30322
7		Chicago	Illinois	United States	60611
8		Chicago	Illinois	United States	60637
9		Kansas City	Kansas	United States	66160
10		New Orleans	Louisiana	United States	70118
11		Detroit	Michigan	United States	48202
12		Rolla	Missouri	United States	65401
13		St. Louis	Missouri	United States	63110
14		Omaha	Nebraska	United States	68198
15		Hackensack	New Jersey	United States	07601
16		Bronx	New York	United States	10467
17	Weil Medical College of Cornell University	New York	New York	United States	10021
18		New York	New York	United States	10021
19		Syracuse	New York	United States	13210
20		Spartanburg	South Carolina	United States	29303
21		Austin	Texas	United States	78701
22		Houston	Texas	United States	77030
23		Abingdon	Virginia	United States	24211
24		Tbilisi		Georgia	GE-380079