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isolated perfusion

Phase 2

Cancer | Small molecule | Oncology |Delcath Systems, Inc.|Last Updated: Oct 23, 2013

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

isolated perfusion · 1 trial · 1 indication

Phase 2 1
NCT00096083Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver CancerCancer
COMPLETED56 Analytics
PHASE2COMPLETED
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration in patients with primary and metastatic hepatic malignancies
Survivial

Secondary Endpoints

To determine the patterns of recurrence following percutaneous hepatic perfusions (PHP) with melphalan
Survival
To determine the progression free and overall survival in patients with hepatic malignancies following this therapy
Survivial
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Melphalan Administration PHPACTIVE_COMPARATOR -

Interventions

NameTypeDescription
isolated perfusionDRUG -
melphalanDRUG -
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatic malignancy * Unresectable disease * Disease predominantly in the parenchyma of the liver * One of the following primary tumor histologies: * Adenocarcinoma of gastrointestinal or other origin * Neuroendocri...

Countries:United States
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Frequently asked questions about isolated perfusion

What is isolated perfusion used for?

Isolated perfusion is used for treating cancer, specifically unresectable liver cancer. It is an investigational therapy being studied in oncology. The treatment involves hepatic arterial infusion of melphalan with hepatic perfusion in patients with unresectable liver cancer.

Who makes isolated perfusion?

Isolated perfusion is being developed by Delcath Systems, Inc., a company traded under the ticker symbol DCTH. The company is conducting clinical research on this therapy for cancer treatment.

What phase is isolated perfusion in?

Isolated perfusion is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The therapy is still undergoing clinical trials to evaluate its safety and effectiveness for treating unresectable liver cancer.

What clinical trials is isolated perfusion in?

Isolated perfusion has one completed clinical trial, identified as NCT00096083. This Phase 2 trial studied hepatic arterial infusion of melphalan with hepatic perfusion in treating patients with unresectable liver cancer. The trial enrolled 56 participants in the United States.

Is isolated perfusion a small molecule therapy?

Yes, isolated perfusion is classified as a small molecule therapy. It is being studied in the oncology therapeutic area for the treatment of cancer, specifically unresectable liver cancer.