What side effects are associated with this type of intervention?

Common treatments for liver cancer, particularly those involving direct injection or immunotherapy like DCVax-Direct, include transcatheter arterial chemoembolization (TACE) and immune checkpoint inhibitors. Known side effects of these treatments can include fatigue, fever, nausea, and injection site reactions. More severe side effects may involve liver dysfunction, infections, and immune-related adverse events such as pneumonitis, colitis, and hepatitis. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including sorafenib (Nexavar) and lenvatinib (Lenvima), which are tyrosine kinase inhibitors used for advanced hepatocellular carcinoma (HCC). Additionally, the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) has been approved for unresectable or metastatic HCC, leveraging immune checkpoint inhibition to stimulate the immune response against cancer cells. While DCVax-Direct, which involves direct injection to stimulate an immune response, is still under investigation, these approved treatments highlight the growing role of immunotherapy in liver cancer management.

What other types of research exist?

Promising novel alternatives to DCVax-Direct for liver cancer patients include: 1) Combination of lenvatinib and transarterial chemoembolization (TACE), which has shown improved overall survival and progression-free survival in clinical trials. 2) Dendritic cell (DC) vaccines loaded with tumor-derived autophagosomes (DRibbles), which have demonstrated significant tumor growth inhibition in murine models. 3) DC vaccines using side population cell-associated antigens, which have shown potential in inducing T cell responses and suppressing tumor growth in preclinical studies. 4) Immune checkpoint inhibitors such as nivolumab and ipilimumab, which have been evaluated in various trials for their efficacy in treating advanced melanoma and may have potential applications in HCC.

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Cancer Vaccine

DCVax-Direct for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Northwest Biotherapeutics

Eligibility Criteria Checklist

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

Must have

Age between 18 and 75 years at screening

Karnofsky performance status (KPS) of 70 or higher or Eastern Cooperative Oncology Group (ECOG) 0-1 at screening

Must not have

History of active clinically significant malignancy other than the tumor type for which DCVax-Direct treatment is considered

Inability or unwillingness to return for required visits and follow-up exams

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called DCVax-Direct, which involves injecting immune cells into solid tumors to help fight cancer. It aims to find the best dose and see if it can reduce tumor growth in patients who may not respond to typical treatments. DCVax-Direct is part of a broader category of treatments that enhance the body's immune response to tumors.

Who is the study for?

Adults aged 18-75 with solid tumors like colorectal, liver, pancreatic cancer or melanoma that can't be fully removed. They must have tried at least one treatment before and have a life expectancy over 3 months. Participants need to be in good physical condition (KPS of 70+ or ECOG 0-1), not on high-dose steroids, and able to measure their tumor. They cannot join if they're pregnant, on immunosuppressants, have severe medical conditions, HIV/HTLV, recent other cancers except certain skin/cervical cancers or genetic syndromes.

What is being tested?

The trial is testing DCVax-Direct's safety and effectiveness in shrinking solid tumors. It starts with Phase I to find the best dose followed by Phase II to see if injecting DCVax-Direct into tumors slows their growth.

What are the potential side effects?

Potential side effects are not detailed here but may include typical immune therapy reactions such as inflammation around the injection site, flu-like symptoms including fever and chills, fatigue, allergic reactions or autoimmune responses.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I am mostly able to care for myself and perform daily activities.

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My cancer is confirmed to be advanced or has spread, through tissue analysis.

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My tumor cannot be completely removed due to its location, my doctor's advice, or my personal choice.

Exclusion Criteria

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

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I have no active cancer other than the one for which I'm considering treatment.

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I cannot or do not want to come back for needed follow-ups.

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I have brain metastases or leptomeningeal disease that hasn't been treated.

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I do not have any severe or unstable health conditions.

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I am not pregnant, breastfeeding, and I use effective birth control.

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I have a history of immune system problems or ongoing autoimmune disease.

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I am currently taking medication to suppress my immune system.

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I have not had immunotherapy for cancer in the last 2 years.

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I need to take medication continuously to prevent blood clots.

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I have a genetic condition that increases my cancer risk.

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I do not have any current severe infections.

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I currently have a fever of 101.5°F (38.6°C) or higher.

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: DCVax-DirectExperimental Treatment1 Intervention

DCVax-Direct: autologous, activated dendritic cells for intratumoral injection

0 / 16Eligibility 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

Common treatments for liver cancer include systemic therapies like sorafenib and lenvatinib, which inhibit tumor cell proliferation and angiogenesis, and locoregional therapies such as transarterial chemoembolization (TACE), which delivers chemotherapy directly to the liver tumor while restricting its blood supply. Immunotherapies, including those similar to DCVax-Direct, work by stimulating the body's immune system to recognize and attack cancer cells. DCVax-Direct involves the direct injection of dendritic cells into the tumor, which enhances the immune system's ability to target and destroy cancer cells. This approach is particularly significant for liver cancer patients as it offers a targeted treatment option that can potentially improve survival rates and reduce tumor recurrence by leveraging the body's natural defense mechanisms.

Combination approaches in hepatocellular carcinoma: How systemic treatment can benefit candidates to locoregional modalities.Hepatocellular carcinoma-specific immunotherapy with synthesized α1,3- galactosyl epitope-pulsed dendritic cells and cytokine-induced killer cells.