Lymphedema Clinical Trial
Official title:
Pilot Phase I/II 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 pilot phase I/II 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 may reduce limb edema size in patients with lymphedema.
PRIMARY OBJECTIVES:
I. Safety. II. Tolerability. III. To determine whether recombinant hyaluronidase
(recombinant human hyaluronidase) (rHUPH20) has a role in treatment of secondary lymphedema
resulting from treatment of malignancy.
SECONDARY OBJECTIVES:
I. To evaluate for histologic and/or biomarker correlates of lymphedema or rHUPH20 response.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive recombinant human hyaluronidase subcutaneously (SC) on days 1, 3, 5, and 7
(Phase I) and then on days 1-21 (Phase II) in the absence of disease progression or
unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
| Completed |
NCT06067880 -
Surgical Intervention and Lymphatic Diseases.
|
||
| Active, not recruiting |
NCT04797390 -
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
|
N/A | |
| Completed |
NCT02676752 -
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
|
||
| Completed |
NCT06323200 -
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
|
||
| Completed |
NCT02506530 -
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
|
N/A | |
| Completed |
NCT02253186 -
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
|
N/A | |
| Terminated |
NCT02020837 -
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
|
Early Phase 1 | |
| Recruiting |
NCT01318785 -
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
|
Phase 2 | |
| Enrolling by invitation |
NCT02375165 -
Biomarkers for the Detection of Lymphatic Insufficiency
|
||
| Completed |
NCT00852930 -
Low Level Laser Treatment and Breast Cancer Related Lymphedema
|
Phase 4 | |
| Completed |
NCT01112189 -
Use of Stem Cells in Lymphedema Post Mastectomy
|
Phase 1/Phase 2 | |
| Completed |
NCT02308488 -
Study of Prone Accelerated Breast And Nodal IMRT
|
N/A | |
| Completed |
NCT00743314 -
Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer
|
Early Phase 1 | |
| Recruiting |
NCT06237907 -
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
|
||
| Terminated |
NCT01580800 -
National Breast Cancer and Lymphedema Registry
|
||
| Suspended |
NCT05366699 -
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
|
N/A | |
| Completed |
NCT06249360 -
Lymphatic System Reflux After Lymphatic Operation
|
||
| Completed |
NCT06220903 -
The Effect of Complex Decongestive Therapy in Patients With Lymphedema
|
N/A | |
| Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |