|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001296 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: melphalan Drug: tumor necrosis factor Drug: interferon-gamma Procedure: hyperthermic isolated limb perfusion |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 122 |
| Study Start Date: | February 1992 |
| Estimated Study Completion Date: | October 2000 |
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.
Eligibility| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations More Information
| Study ID Numbers: | 920105, 92-C-0105 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001296 |
| Health Authority: | United States: Federal Government |
|
Interferon-Gamma Isolated Limb Perfusion Melanoma Melphalan TNF |
|
Melphalan Interferon Type II Interferons Melanoma Neuroendocrine Tumors Fever Neuroectodermal Tumors |
Necrosis Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Interferon-gamma, Recombinant |
|
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |
