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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00290004
First received: February 8, 2006
Last updated: September 10, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Leukemia
Lymphoma
Drug: motexafin gadolinium
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

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

Estimated Enrollment: 35
Study Start Date: November 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290004

Locations
United States, California
USC Norris Cancer Hospital
Los Angeles, California, United States, 90033
Scripps Cancer Center
San Diego, California, United States, 92121
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Pharmacyclics
Investigators
Principal Investigator: Andrew Evens, DO Robert H Lurie Comprehensive Cancer Center of Northwestern University
Principal Investigator: Neil E Kay, MD Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00290004     History of Changes
Other Study ID Numbers: PCYC-0223
Study First Received: February 8, 2006
Last Updated: September 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 14, 2014