Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00036257

Collaborator

Cell Pathways (Industry), OSI Pharmaceuticals (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: CP-461	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2002

Actual Study Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Relapsed or refractory chronic lymphocytic leukemia.
Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
Expected remaining life span > or = three months.
ECOG performance status 0 - 2.
18 years or of legal age.
Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
Negative serum pregnancy test, if fertile female.
Willingness and ability to sign an informed consent document.

Exclusion Criteria:

Evidence of CNS involvement.
Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
Previous therapy with Campath.
Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
Concurrent immunotherapy.
Concurrent use of steroids.
Use of an investigational medication or device within 1 month of initiating study therapy.
Patients who have had allogeneic bone marrow transplantation.
Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
AST or ALT > 2.5 times the upper limit of normal.
Any condition or any medication which may interfere with the conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Centers of Florida	Orlando	Florida	United States	32806
2	Albany Regional Cancer Center	Albany	New York	United States	12208
3	Mary Crowley Medical Research Center (US Oncology)	Dallas	Texas	United States	75246
4	Tyler Cancer Center	Tyler	Texas	United States	75702
5	Cancer Care Northwest	Spokane	Washington	United States	99218