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Could a custom vaccine beat kidney cancer?

NCT ID NCT00625755

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a personalized vaccine made from a patient's own tumor cells mixed with immune cells from a healthy donor. The goal was to see if the vaccine is safe and can help the immune system attack advanced kidney cancer. Forty people with stage IV kidney cancer took part. The vaccine was given as a series of injections.

What this could mean

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

Active substance
personalized fusion-cell vaccine made from the patient's own tumor cells and another person's immune cells
What this could lead to
If it works, this could point toward a new way to train the immune system to fight advanced kidney cancer without needing lifelong medication.
What could go wrong
This is an early-phase trial with only 40 people, so it may not work for everyone. 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

40 people

The number who actually took part.

Start date

Dec 2002

Finished

Feb 2008

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: * The patient must be \_\> 18 years of age * The patient must be diagnosed with AJCC stage IV (primary or relasped) RCC * The patient must have a baseline Eastern Cooperative Oncology Group (ECOG) Clinical performance of 0-1 * The patient must have accessible tumor (minimum of 2.5cm in diameter in aggregate and accessible) for vaccine production * The patient must have measurable tumor lesions (using Response Evaluation Criteria in Solid Tumors (RECIST) following resection of tumor lesions(s) used for vaccine production. If the patient has received previous radiation or intra-tumoral investigational treatments, the measurable disease must be outside the previous radiation port or treatment area unless there is documented tumor progression following the completion of therapy. * The patient must have adequate hematologic, hepatic, and renal function parameters within 21 days prior to the first vaccination (day 0 of treatment): * White blood cell(WBC) count \>\_ 3,000 cell/mm3 * Platelet count \>\_ 100,000 platelets/mm3 * Creatine(serum) \<2.0mg/dL * Total bilirubin \<2.0 mg/dL * Serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) \<2.0 x Upper limits of normal * Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) \< 2.0 x Upper limits of normal * The patient must be serologically negative for human immunodeficiency virus (HIV)-1, HIV-2, and human T lymphotropic virus (HTLV)-1 * Female patients of childbearing potential must have negative pregnancy tests, refrain from nursing and must agree ton use appropriate contraception for the duration of the trial * The patient must have signed and dated written informed consent prior to any study procedures. The consent process must be documented in the patient's medical record Exclusion Criteria: * The patient has received prior chemotherapy * The patient's tumor-derived cells do not meet predetermined manufacturing specifications, for example: human leukocyte antigen (HLA) Class 1 molecule expression, sufficient tumor derived cells for vaccine manufacture, or pathologic confirmation of RCC * The patient has received more than 2 prior regimes for treatment of RCC and the most recent is within 2 weeks of the first screening procedure * The patient has received radiation therapy within 2 weeks of the first sceeening procedure * The patient has a clinically significant autoimmune diorder * The patient has an active infection at the time of the first screening procedure requiring parenteral antibiotics * The patient has clinically significant hematolgic, cardiac, renal, or hepatic disease or any other underlying condition that would contraindicate study therapy or confuse interpretation of study results * The patient has any active or clinically significant central nervous system (CNS) metastases * The patient has a previous unrelated malignancy or second malignancy within 5 years prior to the first screening procedure, except from non-melanoma skin cancer and in situ carcinomas * The patient is receiving chronic immunosuppressive, and/or oral steriod treatment * The patient has any other reason in the Investigator's opinion that would make protocol compliance unmanageable or may compromise the patient's ability to give informed consent * The patient has been treated with a non-oncologic investigational drug, biologic or medical device within 30 days of the first screening procedure

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • BIDMC

    Boston, Massachusetts, 02215, United States

More trials for these conditions

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