Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

Phase 1

Terminated

• Conditions: Lymphedema; Malignant Neoplasm
• Interventions: Biological: recombinant human hyaluronidase

• Registration Number: NCT01928030
• Lead Sponsor: Stanford University

Brief Summary

This phase 1-2 trial studies the side effects and the best dose of recombinant human hyaluronidase and to see how well it works in treating lymphedema in patients with cancer. Recombinant human hyaluronidase (r-hu-hyaluronidase, rHuPH20) may reduce limb edema size in patients with lymphedema.

Detailed Description

This is a phase 1, dose-escalation study followed by a phase 2 study.

Phase 1: rHuPH20 subcutaneously (SC) on days 1, 3, 5, and 7

Phase 2: rHuPH20 SC on days 1 to 21

Study Timeline

• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Study Start: 2013-12
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-12
• Results First Submitted: 2016-12-13
• Results First Submitted QC: 2016-12-13
• Results First Posted: 2017-02-07
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
recombinant human hyaluronidase	recombinant human hyaluronidase	Phase 1. 450 units recombinant human hyaluronidase (rHuPH20) administered SC on days 1, 3, 5, and 7 Phase 2: 900 units recombinant human hyaluronidase (rHuPH20) administered SC on days 1 to 21

Primary Outcome Measures

Name	Time	Method
Treatment-related Adverse Events	Up to 1 year	Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment

Secondary Outcome Measures

Name	Time	Method
Reduction in Forearm Volume	Up to 1 year	Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States