LymphedemaPhase 1/2NCT01928030

Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer

A Phase 1/2 study testing recombinant human hyaluronidase in people with Lymphedema and Malignant Neoplasm, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Lymphedema, Malignant Neoplasm
What is being tested?: recombinant human hyaluronidase
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Nov 2015
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University Hospitals and Clinics
Stanford, California, 94305

Other trials in United States

About this study

Official title: 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

Read the 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

Conditions: Lymphedema, Malignant Neoplasm
Being tested: recombinant human hyaluronidase
Medical subject headings: Lymphedema, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

recombinant human hyaluronidaseBiological
Also called Chemophase, rHuPH20
Given SC

Study groups in NCT01928030
Study group	Role	What they receive
recombinant human hyaluronidase	Experimental	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 Receives: Biological: recombinant human hyaluronidase

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-related Adverse Events
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
Measured: Up to 1 year

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Nov 2015

First posted23 Aug 2013 (estimated)
Study startDec 2013
Primary completionNov 2015
Study completionNov 2015

Why it stopped: Low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphedemaStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928030
Sponsor's protocol ID: IRB-27871
Other IDs: NCI-2013-01624, BRS0032, P30CA124435
Status last verified: Dec 2016
First submitted: 20 Aug 2013
Last updated: 21 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

All Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01928030
Acronym / sponsor ID: IRB-27871
Conditions: Lymphedema, Malignant Neoplasm
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low accrual
Enrolment: 3 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Dec 2013
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 23 Aug 2013 (estimated)
Results: Posted 7 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
recombinant human hyaluronidase	Experimental	Biological: recombinant human hyaluronidasePhase 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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
recombinant human hyaluronidaseAlso: Chemophase, rHuPH20Given SC	Biological	recombinant human hyaluronidase

Primary outcome

Treatment-related Adverse Events
Time frame: 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

1 secondary outcome

Reduction in Forearm Volume
Time frame: Up to 1 year

Results and safety

Results posted to the registry on 7 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
450 Units rHuPH20 (Days 1, 3, 5, and 7)	3	3
900 Units rHuPH20 (Days 1, 3, 5, and 7)	0	0
MTD rHuPH20 (Days 1 to 21)	0	0

Primary outcome: Treatment-related Adverse Events

Time frame: Up to 1 year. Count of participants. Unit: Participants

Measure	450 Units Recombinant Human Hyaluronidase (rHuPH20) n = 3
Value	1

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Recombinant Human Hyaluronidase	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Lymphedema

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Pegram principal investigator

Stanford University

Stanley Rockson principal investigator

School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing recombinant human hyaluronidase in people with Lymphedema and Malignant Neoplasm, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related Adverse Events (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01928030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.