NCT00001296

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 1992

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1992

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Melanoma

Keywords

Interferon-GammaIsolated Limb PerfusionMelanomaMelphalanTNF

Interventions

melphalanDRUG
tumor necrosis factorDRUG
interferon-gammaDRUG
hyperthermic isolated limb perfusionPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Karakousis CP, Choe KJ, Holyoke ED. Biologic behavior and treatment of intransit metastasis of melanoma. Surg Gynecol Obstet. 1980 Jan;150(1):29-32.

    PMID: 7350699BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

MelphalanTumor Necrosis Factor-alphaInterferon-gamma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsGlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesTumor Necrosis FactorsBlood ProteinsProteinsBiological FactorsInterferonsMacrophage-Activating FactorsLymphokines

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

February 1, 1992

Study Completion

October 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-11

Locations

US(1)