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

March 24, 2017 updated by: David Avigan, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • BIDMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
screening/baseline, treatment period, follow-up and long-term follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: screening/baseline, treatment period, follow-up and long-term follow-up
screening/baseline, treatment period, follow-up and long-term follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001P001539
  • DCREN-005-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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