SIR-Spheres® Yttrium 90 for Melanoma

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Chicago, Chicago, IL
Melanoma+4 More
SIR-Spheres® Yttrium 90 - Device
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether a combination of radiation and immunotherapy is safe and effective for patients with uveal melanoma.

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Eligible Conditions

  • Melanoma
  • Neoplasm Metastasis
  • Uveal Neoplasms
  • Hepatic Metastases
  • Melanoma, Uveal

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether SIR-Spheres® Yttrium 90 will improve 1 primary outcome and 4 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 5 years.

5 years
Correlation of tissue markers and response to immunotherapy
Preliminary clinical efficacy
immunological changes
safety and tolerability of sequential selective internal radiation with Yttrium90 followed by immunotherapy with ipilimumab and nivolumab.
5years
Explore relationship of response to immunotherapy with tumor melanin

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
hepatic radiation followed by immunotherapy

This trial requires 26 total participants across 2 different treatment groups

This trial involves 2 different treatments. SIR-Spheres® Yttrium 90 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

hepatic radiation followed by immunotherapySIR-Spheres Yttrium 90 will be given by injection into the hepatic artery in two treatments, one for each lobe. 3-5 weeks later patients receive concurrent ipilimumab 1mg/kg q 3 wk x 4 and nivolumab 3mg/kg q 3 weeks x 4, all followed by nivolumab 240mg/kg q 2 weeks or 480 mg q 4 weeks until progression or 3 years
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5years for reporting.

Closest Location

University of Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No current infection with Hepatitis C. show original
Patients must not have received any other systemic therapies (including chemotherapy, biologic therapy, biochemotherapy, or investigational treatment) in the past other than those given in the adjuvant setting show original
No other investigational therapies; chronic use of systemic corticosteroids; IL-2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; or immunosuppressive agents. show original
According to RECIST, in order to be a valid patient candidate for a tumor therapy study, they must have a measurable disease. show original
Patients who have undergone selective internal radiation therapy in the past may be eligible to undergo the procedure again if they have shown evidence of progressive disease. show original
Patients must have liver metastasis
Histologic diagnosis of metastatic uveal melanoma.
Age ≥ 18 years.
There is no known infection with HIV in patients who are taking ipilimumab show original
I do not have an active infection with Hepatitis B. show original

Patient Q&A Section

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

Can melanoma be cured?

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Currently, there is no cure for melanoma, but there are several effective treatments that have shown significant success. Some of these treatments are still used today, and may not have been used 10 years ago. The best way to manage melanoma is to stay in your dermatologist’s office in a timely fashion and never let melanoma progress to a more dangerous stage. If melanoma progresses to the point of needing therapy, dermatologists are equipped to treat skin cancer and help patients find a treatment strategy that suits their specific needs. Melanoma can be very painful, and patients should see a dermatologist immediately upon being diagnosed to obtain treatment.

Unverified Answer

What are common treatments for melanoma?

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Melanoma is treated with a variety of therapies. A combination of topical and oral aminolevulinic acid combined with systemic therapy for the purpose of melanoma eradication could be an exciting treatment option for this malignancy.

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What is melanoma?

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Melanoma, which is a tumor originating from a melanocyte, causes the creation of melanin, a substance which helps to form shades within the skin, and melanogenesis, which creates a dark pigment that allows us to have color vision and to absorb wavelengths of light. Melanomas and melanocytes are usually found near the edges of the skin, or a pigmented streak around a mole, nipple or scar. Although not all [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) is a melanoma, the two are related. Treatment of melanoma is often done by removal, which removes or destroys the tumor. It is rare for cancer to start as a mole. There are many types of melanoma, including a type called lentigo maligna.

Unverified Answer

What are the signs of melanoma?

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It has been concluded that early symptoms of melanoma include loss of appetite, swelling of the lymph nodes or pain, an irregular or enlarging growth, and itchiness. If the lesion does not have these symptoms, it is usually benign. It may be useful to have an examination by a physician as well as examining the lesion.

Unverified Answer

How many people get melanoma a year in the United States?

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About 44,300 people are diagnosed with cutaneous melanoma in the United States every year. Melanoma has the third-most mortality of any common cancer in both men and women in the United States.

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What causes melanoma?

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Melanoma develops because cells that normally live in the skin begin developing cells that no longer live in the skin. Over time, those cells undergo mutations in the genes on their chromosomes that cause changes in their appearance. Some of these changes happen early on. Melanomas may be prevented in about 80 percent of cases by early removal of sundamaged skin.

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Does melanoma run in families?

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The presence of family history of melanoma does not provide additional information to the risk for development of melanoma and may lead to undertreatment in this group of patients. It may influence the decision to have preventive measures such as surveillance or intervention.

Unverified Answer

What does sir-spheres® yttrium 90 usually treat?

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Sir-spheres® yttrium 90 used in combination with surgery and regional chemotherapy in the treatment of metastatic melanoma is a safe tool which achieves long-term survival.

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Is sir-spheres® yttrium 90 safe for people?

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The findings indicate that use of yttrium 90 sir-spheres is generally safe for patients with unresectable metastatic disease. The safety profile of SIR-SPY is in a similar manner to that seen with other treatments for secondary bone metastases, namely, p53-directed treatment with radionuclides, radiation therapy and bisphosphonates.

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How serious can melanoma be?

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Melanoma is the fifth leading cause of death in cancer patients, but it accounts for only 0.1-0.2% of all cancer cases in the United States. The U.S. mortality ratio for melanoma is decreasing. Melanoma is difficult to diagnose early in its progress, and when it is finally diagnosed, it often has an advanced stage. The 5-year survival rate for melanoma is 77%; however, this rate drops even further to 40% in those with nodular melanoma or more than 2 mm thick.

Unverified Answer

Has sir-spheres® yttrium 90 proven to be more effective than a placebo?

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It seems that sir-spheres® yttrium 90, an alpha-particle emitting isotope, demonstrates an increase in tumour regressiveness of tumors of various histological stages, but does not appear to be more effective than a placebo in terms of improving the long-term quality of life of patients with melanoma.

Unverified Answer

How does sir-spheres® yttrium 90 work?

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SIR-spheres® Yttrium 90 has shown an antitumor activity, comparable to that of radiotherapy. SIR-spheres® Yttrium 90 showed an antitumor activity comparable to that of the combined therapy of 5-FU and CTX in mice with hepatocellular carcinoma.

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See if you qualify for this trial
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