Isolated Limb Perfusion With Melphalan in Treating Patients With Stage IIIB-IV Melanoma or Sarcoma

July 22, 2015 updated by: Albert Einstein College of Medicine

Isolated Limb Perfusion for Advanced Melanoma or Sarcoma Limited to Extremity With or Without Distant Metastases

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • The patient must have histological-proven primary or recurrent extremity melanoma (or other skin cancer including but not limited to Merkel cell carcinoma) or sarcoma, stage IIIB, IIIC, or IV (American Joint Committee on Cancer [AJCC] staging must be documented in patient's medical record, as determined by computed tomography [CT] of the chest, abdomen and pelvis, and/or whole body positron emission tomography [PET] scan, within six weeks prior to administration of study drug)
  • Patients with stage IV disease who have high tumor burden and extensive symptomatic extremity disease
  • Patients with stage IIIC disease must either have had regional lymph nodes previously removed or will have them removed either at the time of regional treatment or soon thereafter
  • Disease to be treated by ILP must be unresectable and distal to the planned site of tourniquet placement (which for the leg is generally the apex of the femoral triangle, or for the arm is distal to the deltoid insertion)
  • Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (RECIST updated version 1.1); lesional tissue not necessary for diagnostic or other clinical purposes may be designated prospectively for research tissue banking
  • Hemoglobin >= 8.0 g/dl
  • White blood count (WBC) of >= 2000 m^3
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x the ULN
  • Creatinine =< 1.5 x ULN
  • Patient must have a palpable femoral/radial pulse in the affected extremity
  • Patients must have a life expectancy of > 6 months
  • Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures
  • Patient or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of their protected health information at any institution subject to United States Health Insurance Portability and Accountability Act (US HIPAA) regulations; NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration

Exclusion Criteria:

  • Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
  • Known brain metastasis; patients with neurological symptoms must undergo a CT scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis
  • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
  • Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
  • Pulmonary hemorrhage/bleeding event >= CTCAE grade 2 within 4 weeks of ILP/isolated limb infusion (ILI); any other hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks ILP/ILI
  • Major surgery or significant traumatic injury within 30 days of ILI/ILP
  • Evidence or history of bleeding diathesis or coagulopathy
  • Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration
  • Patients with symptoms or signs of vascular insufficiency; specifically, patients with any history of blood clots or lifestyle altering ischemic peripheral vascular disease will be excluded
  • History of allergic reactions and/or hypersensitivity to melphalan
  • Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
  • Pregnant or nursing women are not eligible for this study
  • Unable to return at the regular required intervals for reassessment, or study drug administration
  • Patients with known heparin induced thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (ILP with melphalan)
Patients undergo ILP with melphalan IV over 60 minutes.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Drug: isolated limb perfusion
Undergo ILP with melphalan
Other Names:
  • isolated limb infusion
Drug: melphalan
Undergo ILP with melphalan
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 years
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.
Time of ILP procedure to date of recurrence, assessed up to 4 years
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.
Time of ILP treatment to time of death, assessed up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Katia Papalezova, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-12-411 (Other Identifier: Albert Einstein College of Medicine)
  • P30CA013330 (U.S. NIH Grant/Contract)
  • NCI-2013-01218 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 11-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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