Isolated Limb Perfusion With Melphalan in Treating Patients With Stage IIIB-IV Melanoma or Sarcoma
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|ClinicalTrials.gov Identifier: NCT02507076|
Recruitment Status : Withdrawn (no enrollment)
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma of the Skin Eccrine Carcinoma of the Skin Recurrent Adult Soft Tissue Sarcoma Recurrent Melanoma Recurrent Skin Cancer Squamous Cell Carcinoma of the Skin Stage III Adult Soft Tissue Sarcoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Adult Soft Tissue Sarcoma Stage IV Melanoma||Drug: isolated limb perfusion Drug: melphalan Procedure: quality-of-life assessment||Not Applicable|
I. This prospective trial will evaluate total response rate, including complete and partial response, in patients with unresectable extremity melanoma (or other skin cancer including but not limited to Merkel cell carcinoma) or soft tissue sarcoma treated with hyperthermic-isolated limb perfusion (ILP) with melphalan.
I. To evaluate the technical parameters including achievement of regional hyperthermia, arterial blood gas (ABG), tourniquet time, and their association with tumor response.
II. To evaluate time to recurrence and progression free survival (PFS) for patients with advanced extremity melanoma or sarcoma who achieved complete response after treatment with ILP with melphalan.
III. To evaluate overall survival rate and duration of survival for patients with advanced melanoma or sarcoma limited to extremity undergoing ILP with melphalan.
IV. To assess quality of life (QOL) score for patients undergoing ILP with melphalan.
Patients undergo ILP with melphalan intravenously (IV) over 60 minutes.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 1 year, and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Isolated Limb Perfusion for Advanced Melanoma or Sarcoma Limited to Extremity With or Without Distant Metastases|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Treatment (ILP with melphalan)
Patients undergo ILP with melphalan IV over 60 minutes.
Drug: isolated limb perfusion
Undergo ILP with melphalan
Other Name: isolated limb infusion
Undergo ILP with melphalan
Procedure: quality-of-life assessment
Other Name: quality of life assessment
- Overall response rate (complete and partial response) assessed by the RECIST v1.1 [ Time Frame: Up to 12 weeks ]Rates of complete and partial response will be computed and reported with their 95% confidence intervals.
- Time to recurrence [ Time Frame: Up to 4 years ]Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula.
- Progression-free survival [ Time Frame: Time of ILP procedure to date of recurrence, assessed up to 4 years ]Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula.
- Overall survival [ Time Frame: Time of ILP treatment to time of death, assessed up to 4 years ]Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507076
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Katia Papalezova||Albert Einstein College of Medicine|