Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

This is an interventional supportive care trial for Lymphedema Read More

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
• Unilateral upper limb secondary lymphedema
• Must have the ability to understand and the willingness to sign a written informed consent document
• Must agree to blood serum assessment including, complete blood count (CBC) with differential; comprehensive metabolic panel and serum osmolality at every sanctioned evaluation; additionally physician may require cardiac evaluation with echocardiogram, electrocardiogram, brain natriuretic peptide or urinalysis if deemed appropriate
• Must consent to multi-bio-frequency impedance analysis (MFBIA); the details are to be covered in consent
• Willing to sign consent for skin biopsies and phlebotomy
• Women of child bearing potential must have a documented negative pregnancy test within 2 weeks prior to day 1 of treatment and agree to use a non-hormonal form of birth control during the duration of the trial therapy

Exclusion Criteria:

• Pregnant or actively breast-feeding
• Bilateral upper extremity edema
• Bilateral manipulation of axilla within the last 24 months
• Active infections
• Receiving concomitant treatment for upper extremity lymphedema, or who have received treatment within the last 14 days
• Known allergic or hypersensitivity reaction to rHUPH20 or any hyaluronidase extracts
• Receiving concomitant diuretics or dihydropyridine class of calcium channel blockers; if an alternative medication is available, patient can become eligible after 3 half-lives of drug discontinued and patient remains medically stable
• Grade 2 or greater hypo-albuminemia, serum sodium greater than 150meq/L, serum osmolality greater than 300mOsm/kg or blood urea nitrate/serum creatinine ratio greater than 25, within 7 days of screening
• Unable or unwilling to self/home administer subcutaneous experimental drug; study nurse or physician will train individuals on proper administration techniques
• Unwilling or incapable of maintaining a detailed log of number of injections, the date, time and site of administration
• Active malignancy; those undergoing active treatment for malignancy in the adjuvant setting are eligible; treatment can include chemotherapy, targeted therapy or anti-hormonal therapy
• At least 4 weeks removed from surgery or radiation in affected arm
• Primary lymphedema; if edema can be explained by systemic or congenital illnesses, that patient will not be eligible for this study
• Must not have any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
• Must not have received any investigational agents within 30 days prior to commencing study treatment
• Active thrombophlebitis
• Pulmonary edema, congestive heart failure or pulmonary embolus