Status:
COMPLETED
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 l...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00290004
Start Date
November 1 2005
End Date
February 1 2007
Last Update
September 11 2008
Active Locations (4)
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1
USC Norris Cancer Hospital
Los Angeles, California, United States, 90033
2
Scripps Cancer Center
San Diego, California, United States, 92121
3
Northwestern University
Chicago, Illinois, United States, 60611
4
The Mayo Clinic
Rochester, Minnesota, United States, 55905