Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Personalized Monitoring of Intravenous Busulfan Dosing for Patients with Lymphoma Undergoing Autologous Stem Cell Transplantation
IRB CASE 1412
CC 13-644
Hospital Main Campus
Disease Lymphoma, Lymphoma - Hodgkin, Lymphoma - Non - Hodgkin
Drug Busulfan
Description
Primary Objective- To determine the feasibility of real-time therapeutic dose monitoring (TDM) for once daily IV busulfan administration as part of a preparative regimen for patients with lymphoma undergoing autologous stem cell transplantation.
- To compare the incidence of adverse events including mucositis, liver toxicity, seizures, and pulmonary toxicity with TDM of once daily IV busulfan compared to historic controls.
- To determine the proportion of patients who would not have achieved desired busulfan level with weight-based busulfan dosing and therefore required TDM.
Inclusion Criteria
- Patients with either Hodgkin Lymphoma or non-Hodgkin Lymphoma.
- Patients with a previously harvested hematopoietic stem cells while in complete or partial remission, or in the case of patients with stable or refractory disease are undergoing autologous transplantation because it has been recommended by their treating physician as representing their best treatment option with a goal of at minimum of 2 x 106 CD34+ peripheral primed stem cells per kilogram of actual body weight.
- Cardiac ejection fraction ≥45% or clearance by CCF physician.
- DLCO of ≥45% predicted or clearance by CCF physician.
- Serum creatinine <2.0 mg/dl, a serum bilirubin <2.0 mg/dl, and a serum AST.
- Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method.
- Patient must not have any other active malignancy (or malignancy must be in remission with no evidence of disease for the past 2 years) excluding nonmelanoma skin cancer.
- Patients must have had at least 17 days since their most recent cytoxic chemotherapy or radiation at the time of the initiation of their preparative regimen (day -9).
- (SGOT) <2 times the normal or clearance by a CCF physician.
- Patients who are HIV positive:
- Patients must be receiving concurrent HAART therapy (Highly Active Antiretroviral Therapy)
- CD4 count must be ≥100/mm3
- Viral load must be ≤10,000 copies/ml
- Patients must not have concurrent opportunistic infections
- There is no restriction on the number of prior chemotherapeutic regimens or radiation exposure with the exception of prior autologous or allogeneic stem cell transplantation.
- Age ≥2 years.
- ECOG Performance status ≤ 2 at time of consent
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with uncontrolled seizures as defined by having any seizure activity within the 3 months prior to screening.
- Patients who are receiving any other investigational agents.
- Patients with untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Busulfan other agents used in this study.
- Patients receiving any medications or substances that are inhibitors or inducers of specify CYP450 enzyme(s) will be eligible for the study at the discretion of the consenting physician. Lists including medications or substances known or with the potential to interact with the specify CYP450 enzyme(s) isoenzymes are provided in Appendix B.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because busulfan, cyclophosphamide, and etoposide are chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with busulfan, cyclophosphamide, and etoposide, breastfeeding should be discontinued if the mother is treated with busulfan, cyclophosphamide, and etoposide. These potential risks may also apply to other agents used in this study.
- Patients who have had major surgical procedures or significant traumatic injury within 28 days prior to study treatment.