- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928030
Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer
February 13, 2017 updated by: Mark Pegram, Stanford University
Pilot Phase 1-2 Investigational Study to Assess the Efficacy and Safety of Recombinant Hyaluronidase (rHUPH20) in the Treatment of Secondary Lymphedema Resulting From Local Management of Malignancy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University Hospitals and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
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Given SC
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related Adverse Events
Time Frame: Up to 1 year
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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
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Up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Forearm Volume
Time Frame: Up to 1 year
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Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume
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Up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Pegram, Stanford University
- Principal Investigator: Stanley Rockson, School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
August 20, 2013
First Submitted That Met QC Criteria
August 20, 2013
First Posted (ESTIMATE)
August 23, 2013
Study Record Updates
Last Update Posted (ACTUAL)
March 21, 2017
Last Update Submitted That Met QC Criteria
February 13, 2017
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-27871
- P30CA124435 (U.S. NIH Grant/Contract)
- NCI-2013-01624 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- BRS0032 (OTHER: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphedema
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Lymphatica Medtech SATerminatedLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmSwitzerland
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Maastricht University Medical CenterRadboud University Medical Center; Erasmus Medical CenterRecruitingLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmNetherlands
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Tactile MedicalVanderbilt University Medical CenterRecruitingLymphedema | Lymphedema, Secondary | Lymphedema; Surgical | Lymphedema of Face | Lymphedema Due to RadiationUnited States
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ThuasneUniversity Hospital, Tours; Delta ConsultantsCompletedLymphedema, Secondary | Lymphedema of Leg | Lymphedema Congenital | Lymphedema PrimaryFrance
-
Odense University HospitalDanish Cancer SocietyActive, not recruitingPathologic Processes | Neoplasms | Skin Diseases | Lymphatic Diseases | Postoperative Complications | Breast Cancer | Breast Diseases | Lymphedema | Breast Neoplasm | Surgery | Secondary Lymphedema | Breast Cancer Lymphedema | Lymphedema, Breast Cancer | Lymphedema of Upper Limb | Lymphedema Arm | Iatrogenic Lymphedema | A... and other conditionsDenmark
-
Swansea Bay University Health BoardSwansea University; Huntleigh Healthcare Ltd; Lymphoedema Wales Clinical NetworkCompleted
-
ResMedLymphatic Solutions, LLCCompletedLymphedema | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema PrimaryUnited States
-
University of OttawaMcGill University; Horizon Health Network; University of New Brunswick; New Brunswick...UnknownLymphedema of Upper Limb | Mastectomy Related Lymphedema | Lymphedema of Lower Extremity
-
Odense University HospitalZealand University Hospital; Vejle Hospital; Herlev and Gentofte HospitalRecruitingLymphedema | Breast Cancer Lymphedema | Lymphedema, Breast Cancer | Lymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema Arm | Lymphedema; SurgicalDenmark
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University Hospital, MontpellierCompletedPrimary Lymphedema Secondary LymphedemaFrance
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Tissa Hata, MDCompleted
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