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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290004
• Other study ID #: PCYC-0223
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 8, 2006
• Last updated: September 10, 2008
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: September 2008
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• motexafin gadolinium

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	USC Norris Cancer Hospital	Los Angeles	California
United States	The Mayo Clinic	Rochester	Minnesota
United States	Scripps Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I
Primary	To determine the maximum tolerated dose (MTD) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL
Primary	To determine the dose-limiting toxicities (DLTs) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL
Primary	Phase II
Primary	To assess the complete and partial response rate in patients with relapsed or refractory CLL/SLL when administered MGd once weekly at the MTD