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
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ClinicalTrials.gov Identifier: NCT00001296 |
Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.
Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.
Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Drug: melphalan Drug: tumor necrosis factor Drug: interferon-gamma Procedure: hyperthermic isolated limb perfusion | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 122 participants |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 1992 |
Study Completion Date : | October 2000 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00001296
United States, Maryland | |
National Cancer Institute (NCI) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001296 |
Other Study ID Numbers: |
920105 92-C-0105 |
First Posted: | December 10, 2002 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | November 1999 |
Interferon-Gamma Isolated Limb Perfusion Melanoma Melphalan TNF |
Melanoma Necrosis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Pathologic Processes Interferons Interferon-gamma |
Melphalan Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |