Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Vaccines

Dendritic Cell Tumor Fusion Vaccine

David Avigan, MD

The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

* To create the study vaccine, cells will be removed from the participants tumor and fused (mixed) with powerful immune system stimulating cells (dendritic cells) obtained from the participants blood.
* Not everyone who participates in this study will be receiving the same amount of study vaccine. A small group of people will be enrolled into the study and given a certain dose. If they tolerate it well, the next group of people enrolled will receive a higher dose. This will continue until the highest dose level tolerated is determined.
* Once the screening tests are completed and it is determined the participant is eligible, they will undergo some baseline procedures. In an effort to make the study vaccine, tumor cells and dendritic cells will be collected from the participant. Tumor cells may be collected from bone marrow or from a collection of tumor cells called a plasmacytoma. A decision will be made based upon the location of the cancer.
* A bone marrow aspiration/biopsy will be performed during the following time points: at screening, prior to the first vaccination, and at 1 month, 3 months, and 6 months after the final study vaccination. These will be used to assess and follow the participants multiple myeloma.
* Leukapheresis will be performed to obtain dendritic cells. This procedure takes 2 to 4 hours to and involves the collection of a large number of white blood cells. Dendritic cells will be generated in the laboratory from white blood cells. If not enough white blood cells are collected, the participant may be asked to return to the clinic for an additional leukapheresis procedure.
* Before each vaccine is administered (weeks 0, 3, 6) the following study tests and procedures will be performed: skin test; blood test, physical exam and 24-hour urine collection. A physical exam and blood tests will be performed on the weeks when the participant does not receive the vaccine (weeks 1,2,4,5,7,8).
* The study schedule will consist of a fixed dose of the fused (mixed) cell vaccine under the skin every 3 weeks. Each study vaccine will be accompanied by an injection of GM-CSF. Participants will receive 2 or more vaccines depending upon the total number of fusion cells made, the dose the participant is assigned to receive and their response to the study vaccine.
* Follow-up after the vaccine treatment is completed will consist of the following: blood collection (1, 3 and 6 months after final study vaccination); bone marrow aspiration/biopsy (1, 3 and 6 months after final study vaccination); physical exam (1, 2, 3, 4, 5 and 6 months after final study vaccination); radiologic tumor assessment (1, 3 and 6 months after final study vaccination.

The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Dendritic Cell Tumor

Antineoplastic Agents

Molgramostim

Sargramostim

Immunologic Factors

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

Patients treated with DC/RCC vaccine to evaluate response

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

Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

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.

* Patients are being asked to participate if they have chosen to undergo a "debulking nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells in their body) as a standard treatment for kidney cancer or they have tumor lesions that are accessible and are being removed to treat or diagnose their cancer.
* Participants enrolled in this study will be assigned to receive a particular dose of the dendritic cell/tumor fusion vaccine cells. The dose will be determined by when they are enrolled in the study. There are two cohorts to this study. The first cohort will be given the vaccine alone. If the vaccine is well tolerated then we will proceed to the second cohort. The second cohort will receive GM-CSF in addition to the vaccine.
* Tumor cells will be collected to make the study vaccine. Based on the location of the cancer, a decision will be made as to the best approach to obtain these cells.
* Participants will undergo a procedure known as leukapheresis in order to obtain their dendritic cells. Prior to this procedure they will receive 1 to 2 injection of GM-CSF to help increase their white blood cell count.
* If sufficient numbers of cells are obtained, tumor cells and dendritic cells will be fused (mixed) together in the laboratory and divided into the appropriate doses for administration.
* The treatment will consist of 3 vaccinations of fused cells given by an injection under your skin at 3-week intervals. The first six participants will receive only the study vaccine. The remaining participants will receive the study vaccine combined with GM-CSF.
* If enough vaccine cannot be made for the participant to receive 3 doses, the participant may receive only 2 doses of the study vaccine.
* Approximately 3 to 4 tablespoons of blood will be collected at certain times for testing the immune system and to determine if the study vaccine has increased the immune response against the tumor cells. Weekly visits for physical exam, assessment of adverse events and safety labs will be conducted.
* Regular blood draws will be done for at least 6 months following the completion of the study to follow safety labs and to monitor the immune response. Monthly physical exams will be performed following the last injection of the study vaccine. At one month, three months, and six months following the date the participant received the last study vaccine, they will have a CT scan to see if the study vaccine has affected their disease.

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

National Cancer Institute (NCI)

Principal Investigator

Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.

Patients Treated With Vaccine

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions.

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

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

to Correlate Immunologic Response Following Vaccination.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma	NCT00459069	Multiple Myelom...	Dendritic Cell ...	18 Years -	Dana-Farber Cancer Institute
Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF	NCT00458536	Renal Cancer	Dendritic Cell ... Granulocyte Mac...	18 Years -	Beth Israel Deaconess Medical Center
The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma	NCT00459069	Multiple Myelom...	Dendritic Cell ...	18 Years -	Dana-Farber Cancer Institute
Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF	NCT00458536	Renal Cancer	Dendritic Cell ... Granulocyte Mac...	18 Years -	Beth Israel Deaconess Medical Center

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