Status:
COMPLETED
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
Lead Sponsor:
Mara Chambers
Conditions:
Breast Cancer
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the drug mesna is able to block a series of chemical changes that occur in the blood of patients who receive the chemotherapy medicine doxorubicin. Th...
Detailed Description
Patients with lymphoma and breast cancer receiving chemotherapy regimens that include anthracycline drugs, such as doxorubicin, are at risk for developing cognitive and cardiac impairment. This potent...
Eligibility Criteria
Inclusion
- Participants must have histologically or cytologically confirmed breast cancer or non-hodgkin lymphoma and independent of protocol eligibility be determined to require one of the chemotherapy regimens listed below
- Participants must require as standard-of-care treatment a chemotherapy regimen that includes one of the following combinations:
- doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2;
- doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2, and docetaxel 75 mg/m2;
- doxorubicin 50 mg/m2, cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 (capped at 2 mg dose), and prednisone 100 mg +/- rituximab 375 mg/m2
- Age \>18 years.Because these treatment regimens are rarely used in pediatric oncology, children are excluded from this study but will be eligible for future pediatric phase 2 trials.
- Life expectancy of greater than 6 months.
- Zubrod performance score 2 or better.
- Patients must have normal organ and marrow function as defined below:
- leukocytes \>3,000/microliter (mcL) (unless due to cancer in marrow)
- absolute neutrophil count \>1,500/mcL (unless due to cancer in marrow)
- platelets \>100,000/mcL (unless due to cancer in marrow)
- total bilirubin \<1.5 X normal institutional limits
- Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) \<2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- left ventricular function ≥ 50 % ejection fraction
- Because the standard of care chemotherapy agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial because progressive neurologic dysfunction would confound the evaluation of neuro-cognitive outcomes.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to mesna or other agents used in the study (ie. sulfur containing drugs including "sulfa antibiotics" and celecoxib).
- Patients requiring ongoing pharmacologic treatment of dementia are excluded.
- 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 women are excluded from this study because the chemotherapy agents have known teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated with chemotherapy.
- HIV-positivity is NOT a specific exclusion criteria.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01205503
Start Date
September 1 2010
End Date
April 1 2015
Last Update
February 24 2016
Active Locations (1)
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1
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536