Could a custom vaccine beat kidney cancer?
NCT ID NCT00625755
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Renal cell carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Can two drugs shrink kidney tumors and their vein clots before surgery?
- Blood test aims to catch Cancer's return earlier
- Can a new drug target Hard-to-Treat kidney and ovarian cancers?
- Personalized dosing could tame kidney cancer Drug's side effects
- Can teaching patients about immunotherapy cut severe side effects?
- Can a year of sunitinib delay kidney Cancer's return after lung surgery?