Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection

Summary: RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in patients at high risk for a catheter-related infection. It is not yet known whether heparin is more effective than M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.
  PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared with M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.

Detailed description: OBJECTIVES:
  Primary
  -  Compare the incidence of catheter-related infections (Staphylococcal and Candida) in patients at high risk for a catheter-related infection treated with heparin vs minocycline hydrochloride and edetate calcium disodium (M-EDTA).
  Secondary
  -  Compare the incidence of catheter occlusions in patients treated with these regimens.
  OUTLINE: This is a randomized, double-blind, prospective, multicenter study. Patients are stratified according to type of catheter (tunneled central venous catheter [CVC] vs nontunneled percutaneous CVC) and participating center. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA) flush solution into the CVC once daily.
  -  Arm II: Patients receive heparin flush solution into the CVC once daily. Treatment in both arms continues for up to 3 months in the absence of unacceptable toxicity or until the removal of the catheter.
  PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  At high risk of acquiring a catheter infection, as evidenced by any of the following:
  -  Diagnosis of leukemia, lymphoma, myeloma, or melanoma-sarcoma
  -  Undergoing hematopoietic stem cell transplantation
  -  Receiving aldesleukin
  -  Pediatric cancer patients
  -  New (≤ 10 days old) functioning externalized tunneled or nontunneled central venous catheter (CVC), such as a Hickman/Broviac or Hohn catheter, or peripherally inserted central venous catheter (PICC) utilized for infusion of chemotherapy, blood and blood products, or other intermittent infusions
  -  No occluded CVC
  -  No existing local or systemic catheter infection
  -  More than 3 days since removal of a prior CVC due to an infection
  -  No externalized CVC that is projected to remain in place for < 2 weeks
  -  No infusion ports or Groshong catheters
  -  No coated CVC impregnated with an antimicrobial or antiseptic agent
  PATIENT CHARACTERISTICS:
  -  Life expectancy ≥ 3 months
  -  No history of allergy to any tetracycline
  -  No contraindication to flush solution dwell time of ≥ 4 hours
  -  No hypocalcemia while receiving calcium supplementation through the catheter
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant