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Experimental vaccine trains immune system to attack kidney tumors

NCT ID NCT00458536

Disease control Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tested a personalized vaccine made from a patient's own tumor cells fused with immune cells (dendritic cells) to treat stage IV kidney cancer. The vaccine was given with a drug called GM-CSF to boost immune response. The main goal was to check safety and side effects in 38 participants, and to see if the vaccine triggered an immune response against the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dendritic cell/tumor fusion vaccine with GM-CSF
What this could lead to
If successful, this approach could point toward a new way to stimulate the immune system to fight advanced kidney cancer.
What could go wrong
This is an early-phase trial with only 38 participants, so results may not apply broadly. The vaccine is personalized and complex, and side effects or lack of immune response are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

36 people

The number who actually took part.

Start date

Oct 2004

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with stage IV renal cancer who have not received prior chemotherapy or biological therapy * Patients who are to undergo debulking nephrectomy for independent clinical indications or patients with other sites of accessible disease * Tumor tissue should be at least 2.0cm in longest dimension * Patients should meet prognostic criteria for intermediate or favorable risk disease as defined by Motzer criteria * Measurable metastatic disease as defined by a lesion of at least 1cm outside the lesion used for vaccine generation and exclusive of bony metastases * ECOG Performance Status of 0-2 with greater than six week life expectancy * 18 years of age or older * Lab results within range outlined in protocol Exclusion Criteria: * Patients who have received prior chemotherapy * Clinical evidence of CNS disease. Patients with a history of treated brain metastasis must be stable with no evidence of disease for 3 months * HIV positive * Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure * Pregnant of lactating women * History of clinically significant venous thromboembolism

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Conditions

The condition(s) this trial relates to.

kidney cancer renal carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cancer

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.