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Carcinoma, Renal CellPhase 1/2NCT00050323

Safety/Efficacy of a Vaccine Prepared From Dendritic Cells Combined With Tumor Cells to Treat Advanced Kidney Cancer

A Phase 1/2 study testing Allogeneic DCs and Autologous RCC Tumor Derived Cells in people with Carcinoma, Renal Cell, run by Genzyme, a Sanofi Company at 4 sites in United States.

Completed

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

Official record
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Trial summary

The primary purpose of this study is to determine the safety of injections prepared from donor blood cells fused to a patient's own tumor cells which are then used to treat advanced (Stage IV) kidney cancer (renal cell carcinoma or RCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Allogeneic DCs and Autologous RCC Tumor Derived Cells
How many people
30 participants
Where
4 sitesUnited States
Study dates
Nov 2002to Mar 2004
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 greater than or equal to 18 years of age.
  • The patient must be diagnosed with AJCC Stage IV (primary or relapsed) Renal Cell Carcinoma.
  • The patient must have a Screening Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status of 0-1.
  • The patient must have accessible tumor (minimum of 2.5 cm in diameter in aggregate and accessible as defined in the clinical protocol) for vaccine production.
  • The patient must have measurable tumor lesions (using Response Evaluation Criteria in Solid Tumors [RECIST]) following resection of tumor lesion(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 at Screening: White blood cell (WBC) count greater than or equal to 3,000 cells/mm3; Platelet count greater than or equal to 100,000 platelets /mm3; Creatinine (serum) less than 2.0 mg/dL; Total bilirubin less than 2.0 mg/dL; Serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) less than 2.0 x Upper limits of normal; Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) less than 2.0 x Upper limits of normal
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  • 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 to 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 for the treatment of RCC.
  • The patient has received more than 2 prior regimens 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 screening procedure.
  • The patient has a clinically significant autoimmune disorder.
  • The patient has an active infection at the time of the first screening procedure requiring parenteral antibiotics.
  • The patient has clinically significant hematologic, cardiac, renal, or hepatic disease or any other underlying condition that would contraindicate study therapy or confuse interpretation of study results.
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  • The patient has a history of more than one brain metastasis. Patients with a history of a single brain metastasis must have completed definitive treatment for this metastasis not less than 12 weeks prior to the time of first screening procedure and have remained clinically stable during this interval.
  • The patient has a previous unrelated malignancy or second malignancy within 5 years prior to the first screening procedure, except for non-melanoma skin cancer and in situ carcinomas.
  • The patient is receiving chronic immunosuppressive and/or oral steroid 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

4 sites in 1 country.

United States4 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • UCLA Medical Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Phase 1/2 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma

The primary purpose of this study is to determine the safety of injections prepared from donor blood cells fused to a patient's own tumor cells which are then used to treat advanced (Stage IV) kidney cancer (renal cell carcinoma or RCC). The study will also explore the effect the injections have on the size of the tumor and the response in the patient's immune system following administration.

Read the detailed description

Approximately 30,000 new cases of kidney cancer will be diagnosed in the U.S. in 2002, with renal cell carcinoma (RCC) being the most commonly diagnosed type. For patients with locally advanced or metastatic disease, the treatment options are extremely limited and additional options are warranted. Although RCC is generally considered resistant to chemotherapy, spontaneous regressions in patients with metastatic disease have led to research involving immune-mediated therapeutic approaches. Clinical responses have been observed and additional immune-modulating therapeutics are being studied.

Several such approaches have used dendritic cells (DCs), which are known to be potent antigen presenting cells. An antigen is a protein that, when shown to the immune system in the right way, can trigger the cells of the immune system to recognize, remember and eliminate other cells that also display that specific antigen. The cancerous cells in tumors present antigens in such a way that the body's immune system often fails to recognize and eliminate them. It is theorized that when DCs are fused to tumor cells the resulting fused cells will be capable of presenting tumor antigens in an enhanced manner, thus allowing the body's immune system to recognize the tumor antigens on the cancer itself. If this occurs, the patient's immune system may be specifically stimulated, producing a clinically meaningful immune response against the tumor.

In this study DCs produced from healthy volunteer donors (allogeneic DCs) will be fused to the patient's own tumor cells (autologous tumor cells), using an electrical current. The fused dendritic/tumor cells will be returned to the patient in a series of vaccines, six weeks apart.

The purpose of this trial is to determine whether fusing autologous tumor with allogeneic DCs will, with limited associated toxicity, present tumor antigen in such a way as to stimulate an immune response and also show evidence of tumor response.

Being tested
Allogeneic DCs and Autologous RCC Tumor Derived Cells
Keywords
Stage IV Renal Cell Carcinoma, Kidney Cancer, Cancer (General)
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasms

What participants receive

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

  • Allogeneic DCs and Autologous RCC Tumor Derived CellsDrug

Timeline

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

  1. First posted5 Dec 2002 (estimated)
  2. Study startNov 2002
  3. Study completionMar 2004

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00050323
Sponsor's protocol ID
DCREN-005-01
Status last verified
Mar 2015
First submitted
4 Dec 2002
Last updated
5 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogeneic DCs and Autologous RCC Tumor Derived Cells in people with Carcinoma, Renal Cell, run by Genzyme, a Sanofi Company at 4 sites 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 9 inclusion and 11 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00050323.

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 5 Mar 2015.

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