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


Phase 1
N/A
N/A
Not Enrolling
Both
Melanoma, Sarcoma

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

970131

NCT ID:

NCT00001577

Start Date:

June 1997

Completion Date:

March 2000

Related Keywords:

  • Melanoma
  • Sarcoma
  • Chemotherapy
  • Hyperthermia
  • Isolation perfusion
  • Regional Therapy
  • Melanoma
  • Sarcoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892