Official Title: “Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind

Study Primary Completion Date: December 2007

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.

Intervention(s) in this Clinical Trial

• Drug: heparin
• Drug: minocycline-EDTA

Primary Measures

• Incidence of catheter-related infections during the study period (3 months)

Secondary Measures

• Incidence of catheter occlusions during periods of prophylaxis (e.g., time period in which the catheter is locked with heparin or minocycline hydrochloride and edetate calcium disodium [M-EDTA])

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: M.D. Anderson Cancer Center

Overall Clinical Trial Officials and Contacts

Jorge Cortes, MD Principal Investigator M.D. Anderson Cancer Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00378781

Study ID Number: CDR0000500199

ClinicalTrials.gov Identifier: NCT00378781

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database