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Cancer Vaccine

Vaccine Therapy with/without Fludarabine for Kidney Cancer

Phase 2

Waitlist Available

Led By John P. Hanson, MD

Research Sponsored by St. Luke's Medical Center

Eligibility Criteria Checklist

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

Must have

At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery

Hepatic: SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN), Bilirubin ≤ 1.5 times ULN, Hepatitis C antibody negative, Hepatitis B surface antigen negative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well a combination of vaccine therapy and fludarabine works compared to vaccine therapy alone in treating patients with stage IV kidney cancer.

Who is the study for?

This trial is for adults over 18 with Stage IV kidney cancer, who have a certain amount of tumor that can be surgically removed but also have some disease left in the body. They must not have HIV, active infections, immune system problems, or other cancers in the last 5 years. Participants need normal organ function tests and cannot be pregnant.Check my eligibility

What is being tested?

The study is testing if a vaccine made from a patient's own tumor cells works better alone or when combined with fludarabine, a chemotherapy drug. The goal is to see which method does a better job at getting the immune system to attack and kill cancer cells.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccine and typical chemotherapy-related issues like fatigue, nausea, weakened immunity leading to increased infection risk due to fludarabine.

Eligibility Criteria

Inclusion Criteria

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

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I have at least one cancer spot that can be removed by surgery and one that will stay.

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My liver functions are within normal limits and I don't have hepatitis B or C.

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My cancer has not spread to my brain.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My kidney cancer diagnosis was confirmed through tissue examination.

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My kidney function tests are within the required range.

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The cancer area to be removed is larger than 2.0 cm^3.

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My condition is at stage IV.

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I do not have heart failure, unstable chest pain, or irregular heartbeats.

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

Study Objectives

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

Primary outcome measures

Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years

Safety as measured by NCI common toxicity table at completion of study

Survival as measured by the Kaplan-Meier method at 5 years

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Luke's Medical CenterLead Sponsor

12 Previous Clinical Trials

208,463 Total Patients Enrolled

John P. Hanson, MDPrincipal InvestigatorSt. Luke's Medical Center

7 Previous Clinical Trials

242 Total Patients Enrolled

Media Library

Vaccine Therapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00093522 — Phase 2

Kidney Cancer Clinical Trial 2023: Vaccine Therapy Highlights & Side Effects. Trial Name: NCT00093522 — Phase 2

Vaccine Therapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00093522 — Phase 2

Frequently Asked Questions

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

What level of risk do patients face when undergoing this therapy?

"Since this is a Phase 2 trial, with only data confirming safety and none proving efficacy, the treatment's safety has been rated as an intermediary level of 2."

Answered by AI

Could you provide information about the enrollment status of this scientific experiment?

"According to clinicaltrials.gov, no further participants are being recruited for this trial, which was first posted on August 1st 2004 and most recently updated December 18th 2013. Nevertheless, 423 additional trials remain active with open recruitment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer

2004. "Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00093522.

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