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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02507076
Other study ID # 11-12-411
Secondary ID NCI-2013-0121811
Status Withdrawn
Phase N/A
First received July 22, 2015
Last updated July 22, 2015
Start date April 2012
Est. completion date July 2014

Study information

Verified date July 2015
Source Albert Einstein College of Medicine of Yeshiva University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This pilot clinical trial studies isolated limb perfusion with melphalan in treating patients with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the arteries around the tumor may kill more tumor cells.


Description:

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Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

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Intervention

Drug:
isolated limb perfusion
Undergo ILP with melphalan
melphalan
Undergo ILP with melphalan
Procedure:
quality-of-life assessment
Ancillary studies

Locations

Country Name City State
United States Albert Einstein College of Medicine Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (complete and partial response) assessed by the RECIST v1.1 Rates of complete and partial response will be computed and reported with their 95% confidence intervals. Up to 12 weeks No
Secondary Time to recurrence Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula. Up to 4 years No
Secondary Progression-free survival Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula. Time of ILP procedure to date of recurrence, assessed up to 4 years No
Secondary Overall survival Kaplan-Meier methods will be used. 95% confidence intervals will be computed using Greenwood's formula. Time of ILP treatment to time of death, assessed up to 4 years No
See also
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Completed NCT00288041 - Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma Phase 2
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Completed NCT00072163 - Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma Phase 2