AzTrials
AzTrials

Renal Cell CarcinomaPhase 1/2NCT00625755

A Phase I/II Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusions in Patients With AJCC Stage IV Renal Cell Carcinoma

A Phase 1/2 study testing Electrofusion DC vaccine in people with Renal Cell Carcinoma, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will look how using taken from your tumors and mixed with special immune stimulating cells from another person's blood in given back to you in a series "fusion cell" injections, will effect your body. The primary goal of the study is to see if giving the experimental fusion cell injections is safe. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Electrofusion DC vaccine
Type of treatment
Vaccines
How many people
40 participants
Where
1 siteUnited States
Study dates
Dec 2002to Feb 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • BIDMC

    Boston, Massachusetts, 02215

Other trials in United States

About this study

This study will look how using taken from your tumors and mixed with special immune stimulating cells from another person's blood in given back to you in a series "fusion cell" injections, will effect your body. The primary goal of the study is to see if giving the experimental fusion cell injections is safe. We will also be looking to see what effect the experimental treatment as on your immune system and whether it has an effect on your cancer.

Read the detailed description

Patients undergo tumor aquisition and short-term tumor cell cultures are established. Leukopheresis is performed monocyte-derived DC are generated ex-vivo by standard culture techniques, utilizing GM-CSF and Il-4. PEG fusions are generated, and following irradiation, the vaccine is frozen. The thawed vaccine is administered SC into a single site every three weeks. Each study is examining a dose-escalating strategy based apon the number PEG-fused generated from the PEG process that expressed both tumor cell and DC markers as determined by immune staining.

Being tested
Electrofusion DC vaccine
Keywords
renal cell carcinoma, AJCC Stage IV (primary or relasped) renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrofusion DC vaccineBiological

    To assess the safety and efficacy of vaccinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the safety of 3 serial vaccinations with allogeneic DCs: autologous tumor-derived cells subjected to electrofusion in patients with AJCC stage IV RCC

    Measured: screening/baseline, treatment period, follow-up and long-term follow-up

Secondary outcomes (1)

  1. To determine if 3 serial vaccinations of allogeneic DCs: autologous tumor-derived cells subjected to electrofusion will induce a clinical response as assessed by tumor response and will induce an immune response.

    Measured: screening/baseline, treatment period, follow-up and long-term follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2008 (estimated)
  2. Study startDec 2002
  3. Primary completionJun 2005
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00625755
Sponsor's protocol ID
2001P001539
Other IDs
DCREN-005-01
Status last verified
Jan 2026
First submitted
20 Feb 2008
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Avigan DE, Vasir B, George DJ, Oh WK, Atkins MB, McDermott DF, Kantoff PW, Figlin RA, Vasconcelles MJ, Xu Y, Kufe D, Bukowski RM. Phase I/II study of vaccination with electrofused allogeneic dendritic cells/autologous tumor-derived cells in patients with stage IV renal cell carcinoma. J Immunother. 2007 Oct;30(7):749-61. doi: 10.1097/CJI.0b013e3180de4ce8.

    PubMed 17893567

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Electrofusion DC vaccine in people with Renal Cell Carcinoma, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety of 3 serial vaccinations with allogeneic DCs: autologous tumor-derived cells subjected to electrofusion in patients with AJCC stage IV RCC (time frame: screening/baseline, treatment period, follow-up and long-term follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00625755, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in