What side effects are associated with this type of intervention?

Common treatments for cancer similar to rSIFN-co, such as interferon-based therapies, often have side effects that include flu-like symptoms (fever, chills, fatigue), gastrointestinal issues (nausea, vomiting, diarrhea), and hematologic effects (anemia, leukopenia). Additionally, patients may experience neuropsychiatric symptoms like depression and cognitive changes, as well as injection site reactions. These side effects can vary in severity and may require supportive care or dose adjustments.

What prior FDA approvals exist?

The FDA has approved several interferon-based therapies for cancer treatment. For instance, interferon alfa-2b has been used as adjuvant therapy for high-risk melanoma, demonstrating significant prolongation of relapse-free and overall survival. Additionally, interferon alfa has been evaluated in combination with other agents, such as in the treatment of metastatic neuroendocrine tumors. Other related drugs include pembrolizumab and ipilimumab, which are immune checkpoint inhibitors approved for melanoma and other cancers, enhancing the body's immune response against tumors.

What other types of research exist?

Promising novel alternatives to rSIFN-co for cancer patients in 2024 include: 1) Pembrolizumab, an immunotherapy shown to be effective in advanced soft-tissue and bone sarcomas (SARC028 trial); 2) Sorafenib and everolimus, which have shown promise in unresectable high-grade osteosarcoma (non-randomized phase 2 trial); 3) Zoledronate in combination with chemotherapy and surgery for osteosarcoma (OS2006 trial); 4) Dinutuximab in combination with GM-CSF for recurrent osteosarcoma (Children's Oncology Group study).

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Virus Therapy

rSIFN-co for Cancer

Phase 1

Waitlist Available

Research Sponsored by Sichuan Huiyang Life Science and Technology Corporation

Eligibility Criteria Checklist

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

Must have

Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Has adequate renal function defined as serum creatinine or ≤ 1.5 × ULN and creatinine clearance or ≥ 40 ml/min

Must not have

Chronic use of steroid therapy

Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called rSIFN-co. It begins with small groups of patients to determine the safest and most effective dose. The dose is gradually increased, and patients are monitored for serious side effects.

Who is the study for?

Adults with advanced solid tumors like melanoma, kidney, lung, colorectal carcinoma, prostate cancer, and neuroendocrine tumor that's worsening despite standard therapy. They must have measurable disease per RECIST 1.1 criteria, good organ function (bone marrow, liver, kidneys), ECOG performance status ≤1 (able to carry out light activity), and agree to use contraception if of childbearing potential.

What is being tested?

The trial is testing different doses of a drug called rSIFN-co in patients with various types of advanced cancers. It uses an 'EffTox' method to find the best dose by looking at both effectiveness and safety over time before deciding on the optimal dose for further study.

What are the potential side effects?

While specific side effects are not listed here for rSIFN-co as it's under investigation, common side effects from similar treatments may include fatigue, flu-like symptoms such as fever or chills, injection site reactions and changes in blood counts which could affect organ functions.

Eligibility Criteria

Inclusion Criteria

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

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I can carry out all my usual activities without help.

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My kidney function is within the normal range.

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My cancer is one of the specified types and is getting worse despite treatment.

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My liver is functioning well, with normal bilirubin and enzyme levels.

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My blood tests show normal levels of hemoglobin, white blood cells, and platelets.

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I agree to use contraception if I am not sterile.

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I am not pregnant or breastfeeding and use birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use steroid medication.

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I have not had any non-healing wounds, fractures, or ulcers in the last 28 days.

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I do not have uncontrolled HIV, hepatitis B, or C.

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I am currently being treated for a serious infection.

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I have a severe medical condition that is not under control.

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I am able to understand and agree to participate in the study.

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I have an autoimmune disorder or uncontrolled diabetes.

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I have a history of epilepsy, depression, or other mental health issues.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: sSIFN-coExperimental Treatment1 Intervention

Dose escalation of rSIFN-co

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rSIFN-co

2013

Completed Phase 1

~50

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Interferons, like rSIFN-co, enhance the immune system's ability to fight cancer by boosting immune response, inhibiting cancer cell proliferation, and promoting apoptosis. This is crucial for cancer patients as it targets cancer cells while minimizing damage to normal cells. Other common treatments include chemotherapy, which targets rapidly dividing cells; targeted therapy, which blocks specific molecules involved in cancer growth; and immunotherapy, which enhances the body's immune response against cancer. These treatments offer personalized and potentially more effective options based on the cancer's specific characteristics.

Mature B-NHL in children, adolescents and young adults: current therapeutic approach and emerging treatment strategies.[Adjuvant therapy of melanoma. From non-specific immune stimulants into the future].