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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001577
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition Intervention Phase
Melanoma Sarcoma Procedure: double isolated limb perfusion with melphalan alone Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: June 1997
Estimated Study Completion Date: March 2000
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00001577


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001577     History of Changes
Other Study ID Numbers: 970131
97-C-0131
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: April 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Chemotherapy
Hyperthermia
Isolation perfusion
Regional Therapy

Additional relevant MeSH terms:
Melanoma
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs