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Cytokine

Interleukin-2 +/- Histamine Dihydrochloride for Skin Cancer

Phase 3

Waitlist Available

Research Sponsored by Maxim Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN), AST and ALT no greater than 4 times ULN, Alkaline phosphatase no greater than 4 times ULN, Hepatitis B and C negative

Renal: Creatinine no greater than 1.7 mg/dL, Calcium no greater than 11.5 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well interleukin-2 works with or without histamine dihydrochloride in treating patients with stage IV melanoma that has spread to the liver.

Who is the study for?

This trial is for adults with stage IV melanoma that has spread to the liver. Participants must have measurable liver lesions, no brain metastasis, good performance status, and a life expectancy of at least 3 months. They should not be pregnant or nursing and must use contraception if fertile. Excluded are those with certain heart diseases, severe asthma in the past 5 years, other active cancers (except some skin cancers), autoimmune diseases, peptic ulcers, drug abuse history or hypersensitivity to histamine.Check my eligibility

What is being tested?

The study is testing whether interleukin-2 (a white blood cell stimulator) is more effective alone or when combined with histamine dihydrochloride (which may make cancer cells more sensitive to treatment) in patients with advanced melanoma in the liver. It's a phase III trial where participants are randomly assigned to receive either just interleukin-2 or both drugs.See study design

What are the potential side effects?

Interleukin-2 can cause flu-like symptoms such as fever and chills, fatigue, nausea and vomiting; it might also affect normal blood counts leading to anemia or increased risk of infections. Histamine dihydrochloride could potentially cause allergic reactions or aggravate ulcer disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are within acceptable limits and I don't have hepatitis B or C.

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My creatinine is ≤ 1.7 mg/dL and calcium is ≤ 11.5 mg/dL.

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My melanoma is confirmed to be at stage IV.

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I have at least one cancer spot that can be measured and was not previously treated with radiation.

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My tumor is visible and measurable by scans or physical exam.

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I am fully active or able to carry out light work.

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I am 18 years old or older.

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I have no signs of cancer spreading to my brain.

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My heart is healthy with no recent heart attacks or severe heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

Maxim PharmaceuticalsLead Sponsor

1 Previous Clinical Trials

360 Total Patients Enrolled

John A. Glaspy, MD, MPHStudy ChairJonsson Comprehensive Cancer Center

7 Previous Clinical Trials

135 Total Patients Enrolled

Media Library

Interleukin-2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT00039234 — Phase 3

Skin Cancer Clinical Trial 2023: Interleukin-2 Highlights & Side Effects. Trial Name: NCT00039234 — Phase 3

Interleukin-2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00039234 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being recruited for this research project?

"No, this particular study is not seeking patients at the moment according to clinicaltrials.gov. This research was initially posted on September 1st, 2002 but has not been updated since December 17th, 2013. There are 955 other medical trials that are still recruiting though."

Answered by AI

What is the margin of safety for this experimental procedure?

"This therapeutic intervention has received a score of 3 for safety by our analysts at Power. This is due to the fact that this is a Phase 3 trial, which means there is both efficacy and safety data supporting its use."

Answered by AI

In how many different medical clinics is this medical study being run today?

"Thirteen different hospitals across America are enrolling patients for this study, which include but are not limited to John Wayne Cancer Institute at Saint John's Health Center in Santa Monica, California, University of Colorado Cancer Center at University of Colorado Health Sciences Center in Aurora, Colorado, and Hillman Cancer Center at University of Pittsburgh Cancer Institute in Pittsburgh, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2002. "Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00039234.

All > Liver Fibrosis > Stage Iv Melanoma