Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

NCT00458536 | Completed Phase 1 Results DMC

• 1 other identifier: 04-117
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Conditions

Renal Cancer

Keywords

GM-CSF; vaccine; debulking nephrectomy; dendritic cells

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF

  5 years

Secondary Outcomes (2)

• To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF

  5 years

• to Correlate Immunologic Response Following Vaccination.

  5 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

Patients treated with DC/RCC vaccine to evaluate for treatment-limiting toxicity

Biological: Dendritic Cell Tumor Fusion Vaccine; Drug: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

Cohort 2

EXPERIMENTAL

Patients treated with DC/RCC vaccine to evaluate response

Biological: Dendritic Cell Tumor Fusion Vaccine; Drug: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

Interventions

Dendritic Cell Tumor Fusion Vaccine BIOLOGICAL

3 vaccinations at three week intervals

Cohort 1; Cohort 2

Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) DRUG

Combined with the vaccine in the remaining subjects after the first 6 are enrolled.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage IV renal cancer who have not received prior chemotherapy or biological therapy
• Patients who are to undergo debulking nephrectomy for independent clinical indications or patients with other sites of accessible disease
• Tumor tissue should be at least 2.0cm in longest dimension
• Patients should meet prognostic criteria for intermediate or favorable risk disease as defined by Motzer criteria
• Measurable metastatic disease as defined by a lesion of at least 1cm outside the lesion used for vaccine generation and exclusive of bony metastases
• ECOG Performance Status of 0-2 with greater than six week life expectancy
• years of age or older
• Lab results within range outlined in protocol

You may not qualify if:

• Patients who have received prior chemotherapy
• Clinical evidence of CNS disease. Patients with a history of treated brain metastasis must be stable with no evidence of disease for 3 months
• HIV positive
• Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
• Pregnant of lactating women
• History of clinically significant venous thromboembolism

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: David Avigan, MD
• Organization: Beth Israel Deaconess Medical Center

davigan@bidmc.harvard.edu

617-667-9920

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: October 1, 2004
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2023
• Last Updated: February 9, 2026
• Results First Posted: February 17, 2016

Record last verified: 2026-01

Locations

US (1)