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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is to test a new cancer treatment called DCVax-Direct. They will first find the best dose to give, then see if it can help reduce the size of 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with adverse events

Secondary outcome measures

Number of patients with tumor response

Other outcome measures

Number of patients surviving

Neoplasms

Trial Design

1Treatment groups

Experimental Treatment

Group I: DCVax-DirectExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwest BiotherapeuticsLead Sponsor

7 Previous Clinical Trials

408 Total Patients Enrolled

Marnix Bosch, MBA, PhDStudy DirectorNorthwest Biotherapeutics

Media Library

DCVax-Direct (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT01882946 — Phase 1 & 2

Liver Cancer Research Study Groups: DCVax-Direct

Liver Cancer Clinical Trial 2023: DCVax-Direct Highlights & Side Effects. Trial Name: NCT01882946 — Phase 1 & 2

DCVax-Direct (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01882946 — Phase 1 & 2

Frequently Asked Questions

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

Is the age limit for potential participants in this clinical trial greater than 50?

"In order to be involved in this medical trial, patients must range between 18 and 75 years old. There are 371 studies for minors below the age of consent and 3734 trials targeting seniors over 65."

Answered by AI

What criteria must be met in order to qualify for participation in this research?

"This medical trial is currently looking to recruit 60 patients with a diagnosis of melanoma, aged between 18 and 75. Furthermore, they must adhere to the following criteria: cessation or tapering of steroid dosages two weeks prior; KPS/ECOG score 0-1 at screening; evidence that primary treatments are ineffective for their condition; lack of eligibility for complete resection due to tumor location; completion of recent treatment regimen in advanced setting; measurable tumors > 1 cm diameter accessible for injection with imaging guidance when necessary; adequate hematological, hepatic, renal function & blood coagulation parameters; life expectancy greater than 3 months."

Answered by AI

Is the window of opportunity still open for this trial's participants?

"Per clinicaltrials.gov, this trial is currently not recruiting participants; it was initially posted on June 1st 2013 and last updated October 6th 2015. Nevertheless, there are 3936 medical experiments that are presently looking for volunteers to get involved in the research process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy Study of DCVax-Direct in Solid Tumors

2013. "Safety and Efficacy Study of DCVax-Direct in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01882946.

All > Melanoma > Liver Cancer