Overview

This trial is active, not recruiting.

Condition chemobrain
Treatment mesna
Phase phase 2
Sponsor Mara Chambers
Start date September 2010
End date December 2014
Trial size 40 participants
Trial identifier NCT01205503, 10-0431-F1V

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. The researchers believe these blood chemical changes may the cause of "cloudy thinking" or "chemobrain" that are reported by some patients receiving chemotherapy

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Other)
Saline administered prior to and 3 hours post doxorubicin infusion during 1st cycle Mesna administered prior to and 3 hours post doxorubicin infusion during 2nd cycle
mesna
Mesna: 360 mg/m2 in 50 mL NS cycle 2 day or cycle 1 day 1
(Other)
Mesna administered prior to and 3 hours post doxorubicin infusion during 1st cycle Saline administered prior to and 3 hours post doxorubicin infusion during 2nd cycle
mesna
Mesna: 360 mg/m2 in 50 mL NS cycle 2 day or cycle 1 day 1

Primary Outcomes

Measure
Plasma protein oxidation and TNF-α levels in patients receiving doxorubicin containing chemotherapy
time frame: prior to and 3 hours post doxorubicin

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

  • 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 status 2 or better. Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000/mcL (unless due to cancer in marrow)
  • absoluteneutrophil 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
  • AST(SGOT)/ALT(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 Criteria

    Additional Information

    Official title Randomized, Blinded Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and TNF-α Release
    Principal investigator Mara Chambers, M.D.
    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 potential cognitive impairment is refered to as "chemobrain" by some patients. We have demonstrated in mice that the drug mesna, which is used to prevent other complications of other chemotherapy drugs, prevents certain types of doxorubicin-induced damage of blood proteins. Blocking doxorubicin's damage of these blood proteins has blunted or prevented the subsequent markers of neurologic and cardiac injury in mice. This clinical trial will determine if mesna prevents doxorubicin-induced damage of blood proteins in cancer patients, and may establish if blood protein injury is the first step in anthracycline-induced cognitive and cardiac dysfunction and if using the drug mesna can blunt or prevent these changes in blood markers of injury for patients with cancer.
    Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
    Information provided to ClinicalTrials.gov by University of Kentucky.