Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

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