Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

March 3, 2008 updated by: National Cancer Institute (NCI)

Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule.

These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After perfusion is established, the leak rate has been determined to be acceptable, and tissue temperatures are 38 degrees Celsius, then the melphalan is administered by slow injection into an arterial line over approximately 5 minutes. The perfusion with melphalan will then continue for 60 minutes, after which the extremity is flushed out with a total of 3 liters of fluid consisting initially of a saline solution. The dose of melphalan for the second perfusion will be increased.

An attempt to resect the residual lesion between 6-12 weeks after the second

interval perfusion may be made.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with extremity melanoma (Stage IIIA, IIIAB or Stage IV disease who have bulky symptomatic tumor located in the extremity) or patients with unresectable extremity sarcoma will undergo a double isolated limb perfusion with melphalan alone separated by approximately 4 to 6 weeks. The initial perfusion will be done with a melphalan dose of 6 mg/L limb volume and the interval perfusion with a dose of 9 mg/L limb volume. For patients with extremity sarcoma the tumor will be excised if feasible using a limb sparing resection between 6-12 weeks after the second perfusion. Technical feasibility of the double perfusion schedule will be determined. Overall response, duration of response, patterns of recurrence, and survival will be followed.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

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
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically confirmed unresectable sarcoma or intransit melanoma of the upper or lower extremity.

Extremity sarcoma with no local resection option and would require amputation based upon abutment or proximity of the tumor to major neurovascular structures or bone or joint structures.

MELANOMA PATIENTS:

Must have history of two or more satellite intransit metastases of which one may be excised for diagnosis with the exception of patients with a single, large, deep, locally recurrent tumor or metastatic tumor (greater than 5 cm) that precludes an excision with primary closure. Stage IV melanoma must have a significant component (greater than 90%) of disease distal to the apex of the femoral triangle in the lower limb or distal to the insertion of the deltoid in the upper limb.

Must have evaluable disease in the extremity. Melanoma must have dermal or subcutaneous lesion that can be measure directly in two diameters to assess tumor burden. Sarcoma must have either cutaneous lesions amenable to direct measurement or deeper lesions that can be measured on CT or MRI scans.

PRIOR/CONCURRENT THERAPY:

At least 2 months since any regional therapy to the affected extremity.

BIOLOGIC THERAPY: At least 1 month since Biologic Therapy.

CHEMOTHERAPY: At least 1 month since chemotherapy.

ENDOCRINE THERAPY: Not specified.

RADIOTHERAPY: At least 1 month since radiotherapy.

SURGERY: Not specified.

PATIENT CHARACTERISTICS:

AGE: 18 and over.

PERFORMANCE STATUS: ECOG 0-2.

LIFE EXPECTANCY: At least 6 months.

HEMATOPOIETIC: Platelet count greater than 150,000/mm(3).

HEPATIC: Bilirubin less than 2.0 mg/dL.

RENAL: Creatinine less than 2.0 mg/dL.

CARDIOVASCULAR: No history of congestive heart failure with an LVEF less than 40%.

PULMONARY:

No chronic obstructive pulmonary disease.

No other chronic pulmonary disease with PFTs less than 50% predicted for age.

OTHER:

IF HIV POSITIVE: Must have CD4 cell count greater than 500/mL and, No clinical manifestations of AIDS. Coagulation parameters no greater than 1-2 seconds within the upper limit of normal.

No evidence of severe peripheral vascular disease.

No history of claudication or other ischemic vascular disease.

Not pregnant or nursing.

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

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 1997

Study Completion

March 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

April 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970131
  • 97-C-0131

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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