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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
motexafin gadolinium
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma, Motexafin Gadolinium, Relapsed Chronic Lymphocytic Leukemia, Relapsed Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • USC Norris Cancer Hospital
  • Scripps Cancer Center
  • Northwestern University
  • The Mayo Clinic

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2006
Last Updated
September 10, 2008
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00290004
Brief Title
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma, Motexafin Gadolinium, Relapsed Chronic Lymphocytic Leukemia, Relapsed Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Primary Outcome Measure Information:
Title
Phase I
Title
To determine the maximum tolerated dose (MTD) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL
Title
To determine the dose-limiting toxicities (DLTs) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL
Title
Phase II
Title
To assess the complete and partial response rate in patients with relapsed or refractory CLL/SLL when administered MGd once weekly at the MTD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Evens, DO
Organizational Affiliation
Robert H Lurie Comprehensive Cancer Center of Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil E Kay, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Cancer Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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