Status:
COMPLETED
Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.
Detailed Description
Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. They are commonly used in stem cell transplantation. G...
Eligibility Criteria
Inclusion
- Age 18 - \<70 years.
- Patients with lymphoid malignancies who do not qualify for treatment protocols of higher priority: 2.1) Primary refractory/recurrent Hodgkin's disease 2.2) Primary refractory/recurrent non-Hodgkin's lymphoma 2.3) Multiple myeloma beyond first remission or unresponsive to therapy, who do not qualify for higher priority melphalan-based protocols.
- Adequate renal function, as defined by estimated serum creatinine clearance \>/= 50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
- Adequate hepatic function, as defined by Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) \</= 3 \* upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 \* upper limit of normal.
- Adequate pulmonary function with forced expiratory volume for 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) \>/= 50% of expected corrected for hemoglobin or volume.
- Adequate cardiac function with left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status \<2.
- Patient should be willing to participate in the study by providing written consent.
- Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Exclusion
- Patients with grade \>/= 3 non-hematologic toxicity from previous therapy that has not resolved to grade 1.
- Patients with prior whole brain irradiation
- Patients with active hepatitis B virus (HBV), either active carrier (HBsAg +) or viremic (HBV DNA \>=10,000 copies/mL, or \>= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- Human immunodeficiency virus (HIV) infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
- Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00410982
Start Date
December 1 2006
End Date
September 1 2012
Last Update
June 3 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030