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Not listed Phase 3 Interventional

Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

ClinicalTrials.gov ID: NCT00039234

Public ClinicalTrials.gov record NCT00039234. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multi-Center Controlled Trial With Stratified Randomization Comparing The Efficacy Of Interleukin-2 (IL-2) Plus Histamine Dihydrochloride (HDC) Versus IL-2 Alone To Increase The Duration Of Survival In Patients With AJCC Stage IV Malignant Melanoma With Hepatic Metastasis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver. PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver.

Study identification

NCT ID
NCT00039234
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Maxim Pharmaceuticals
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2002
Primary completion
Not listed
Completion
Not listed
Last update posted
Dec 17, 2013

Started 2002

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
John Wayne Cancer Institute at Saint John's Health Center Santa Monica California 90404
University of Colorado Cancer Center at University of Colorado Health Sciences Center Aurora Colorado 80010
Moffitt Clinic at Tampa General Hospital Tampa Florida 33612
University of Chicago Cancer Research Center Chicago Illinois 60637-1470
James Graham Brown Cancer Center at University of Louisville Louisville Kentucky 40202
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri 65203
Melanoma Center of St. Louis, Missouri Baptist Medical Center St Louis Missouri 63131
Beth Israel Medical Center New York New York 10003
Memorial Sloan-Kettering Cancer Center New York New York 10021
Comprehensive Cancer Center at Our Lady of Mercy Medical Center The Bronx New York 10466
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania 15213-3489

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00039234, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2013 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00039234 live on ClinicalTrials.gov.

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