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A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma


Phase 3
N/A
N/A
Not Enrolling
Both
Melanoma

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Trial Information

A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma


Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB)
will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion.
One arm of the study will be a standard 60 minute perfusion with melphalan as a single
agent. The second arm of the study will combine melphalan, tumor necrosis factor, and
interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100%
response rates in a Phase II European trial. Patients will be followed for local response
rates, duration of response, treatment toxicity, and disease-free survival.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity,
as follows:

Advanced local disease indicated by 2 or more satellite or in-transit metastases.

Lower limb regional metastases must be distal to the apex of the femoral triangle except
inguinal lymph node metastases.

Upper limb regional metastases must be distal to the deltoid insertion except axillary
lymph node metastases.

No evidence of systemic disease outside the involved extremity.

Recurrent disease subsequent to prior successful limb perfusion allowed.

Bidimensional directly measurable dermal or subcutaneous lesion required.

PRIOR/CONCURRENT THERAPY:

No prior isolated limb perfusion.

Biologic Therapy: At least 1 month since Biologic Therapy.

At least 3 months since regional therapy of the extremity.

Chemotherapy: At least 1 month since chemotherap.y

At least 3 months since regional therapy of the extremity.

Endocrine Therapy: Not specified.

Radiotherapy: At least 1 month since radiotherapy.

Surgery: Not specified.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0 or 1.

Hematopoietic: Platelets greater than 150,000.

Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.

Renal: Creatinine less than 2.0 mg/dl.

Cardiovascular: No evidence of peripheral vascular disease, e.g.:

No history of claudication.

OTHER:

HIV negative.

No pregnant or nursing women.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

920105

NCT ID:

NCT00001296

Start Date:

February 1992

Completion Date:

October 2000

Related Keywords:

  • Melanoma
  • Interferon-Gamma
  • Isolated Limb Perfusion
  • Melanoma
  • Melphalan
  • TNF
  • Fever
  • Melanoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892