Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor

Pharmacyclics LLC. (Industry)

Overall Status

Completed

CT.gov ID

NCT00290004

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia Lymphoma	Drug: motexafin gadolinium	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Trial of Weekly Motexafin Gadolinium (MGd) for Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Phase I []
To determine the maximum tolerated dose (MTD) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL []
To determine the dose-limiting toxicities (DLTs) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL []
Phase II []
To assess the complete and partial response rate in patients with relapsed or refractory CLL/SLL when administered MGd once weekly at the MTD []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years old
CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following:
Refractory disease: progressive disease while on therapy
Relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
ECOG performance status score of 0, 1, or 2
Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory values of:
Platelet count < 30,000/µL
AST or ALT > 2 x ULN (upper limit of normal)
Total bilirubin > 2 x ULN
Creatinine > 2 mg/dL
Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
Major surgery or hospitalization for a serious illness within the last 3 months
Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
Prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
Uncontrolled hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Norris Cancer Hospital	Los Angeles	California	United States	90033
2	Scripps Cancer Center	San Diego	California	United States	92121
3	Northwestern University	Chicago	Illinois	United States	60611
4	The Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Pharmacyclics LLC.

Investigators

Principal Investigator: Andrew Evens, DO, Robert H Lurie Comprehensive Cancer Center of Northwestern University
Principal Investigator: Neil E Kay, MD, Mayo Clinic