NCT00290004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

September 11, 2008

Status Verified

September 1, 2008

Enrollment Period

1.3 years

First QC Date

February 8, 2006

Last Update Submit

September 10, 2008

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaLeukemiaLymphoma

Keywords

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaLeukemiaLymphomaMotexafin GadoliniumRelapsed Chronic Lymphocytic LeukemiaRelapsed Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

motexafin gadoliniumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

USC Norris Cancer Hospital

Los Angeles, California, 90033, United States

Location

Scripps Cancer Center

San Diego, California, 92121, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemiaLymphoma

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Evens, DO

    Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    PRINCIPAL INVESTIGATOR

  • Neil E Kay, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

September 11, 2008

Record last verified: 2008-09

Locations

US(4)