Search / Trial NCT00001296

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Interferon Gamma Isolated Limb Perfusion Melanoma Melphalan Tnf

Description

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-...

Gender

All

Eligibility 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.

Attachments

readout_NCT00001296_2023-12-10.pdf

4.5 MB

NCT00001296_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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