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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase I

Principal Investigator

Andrew Evens, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H Lurie Comprehensive Cancer Center of Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0223

NCT ID:

NCT00290004

Start Date:

November 2005

Completion Date:

February 2007

Related Keywords:

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

Name

Location

Northwestern UniversityChicago, Illinois  60611
Scripps Cancer CenterLa Jolla, California  92037
The Mayo ClinicRochester, Minnesota  55905
USC Norris Cancer HospitalLos Angeles, California  90033