Type of Cancer Treated

Title of Study

Vaccine Name (if applicable)

Lead Institution

Nature of Vaccine

Purpose of the Study

Start Date and Links

Breast

Study of Theratope Vaccine in Metastatic Breast Cancer Patients

Theratope

Biomira Inc.

EMD Pharmaceuticals

Merck KGaA

Theratope vaccine contains a synthetic version of a carbohydrate antigen, sialyl Tn, (STn), which is frequently found on the outer  surface of many cancer cells.  Synthetic STn is fused to KLH to promote an immune response.

Compare disease progression and survival of women being treated with aromatase inhibitors or Faslodex to those treated with Theratope plus aromatase inhibitors or Faslodex.

2001

NCT00046371

Follicular B-cell

Non-Hodgkin's Lymphoma

Randomized Trial of Patient-specific Vaccination With Conjugated Follicular Lymphoma-derived Idiotype With Local GM-CSF in First Complete Remission

Not Named

National
Cancer
Institute

The vaccine is composed of  portions of antibodies that are unique to  a patient's own tumor cells.  These iodiotype proteins are chemically attached to KLH. GM-CSF is used to enhance the immune response.

To compare two vaccination groups: Group I patients receive injections of the vaccine plus GM-CSF.  Group II patients receive injections containing only KLH and GM-CSF.

January 2000

www.ncilymphoma
vaccine.org

Protocol:00-C-0050

Follicular B-cell

Non-Hodgkin's Lymphoma

Combination Chemotherapy Followed by Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

GTOP-99

Genitope
Corporation

The vaccine consists of portions of antibodies that are unique to a  patient's tumor.  This idiotype protein is chemically attached to the adjuvant protein, KLH.  GM-CSF (Sargramostim) is also used to enhance the immune response.

To evaluate time to tumor progression in patients who receivevaccines compared to controls who receive adjuvant alone and GM-CSF alone.

November 2000

NCT00017290

Kidney

Survival Study of Oncophage® vs. Observation in Patients With Kidney Cancer

Oncophage
(HSPPC-96)

Antigenics

The vaccine -- heat shock proteins (gp 96 ) and associated peptides -- is made from individual patients' tumors.

To determine whether patients receiving Oncophage treatment for surgically removed non-metastatic renal cell carcinoma survive longer than patients who do not receive vaccine treatment.

December 2000

NCT00033904

Lung

Survival in a Randomized Phase III Trial in Patients With LD Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

BEC2 Vaccine

European
Cooperative
(EORTC)

The vaccine contains a mouse antibody engineered to resemble the human protein GD3 ganglioside,  found on small cell lung cancers.  The vaccine combines the antibody, BEC2, with the adjuvant, BCG.

To determine whether vaccinated patients survive longer than patients who do not receive vaccine.

September 1998

NCT00037713

Melanoma

Study of Heat Shock Protein-Peptide Complex (HSPPC-96) vs. IL-2/DTIC for Stage IV Melanoma

Oncophage
(HSPPC-96)

Antigenics

The vaccine -- heat shock proteins and associated peptides -- is made from individual patient's tumor.

To determine if people with metastatic melanoma who receive Oncophage after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including interleukin-2 /dacarbazine/temozolomide-based therapy.

March 2002

NCT0003900

Melanoma

Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Not Named

European
Cooperative
(EORTC)

The vaccine consists of GM2, a common antigen on melanoma cells, which is conjugated to the adjuvant, KLH.   QS21 is used to enhance the immune response.

To compare the disease-free and overall survival of  stage II  melanoma patients receiving the vaccine to those not receiving the vaccine.

February 2002

NCT00005052

Melanoma

Vaccine Therapy in Treating Patients With Melanoma of the Eye

Not Named

European
Cooperative
(EORTC)

The vaccine contains several melanoma differentiation peptides.

To determine the effectiveness of vaccine therapy in preventing liver metastasis and increasing survival in patients at high risk for recurrent melanoma of the eye.

February 2002

NCT00036816

Melanoma

Vaccine Therapy and/or Sargramostim in Treating Patients With Locally or Advanced Metastatic Melanoma

Not Named

National
Cancer
Institute

The vaccine contains a combination of  3 melanocyte-specific antigens: tyrosinase, gp100, and MART.

GM-CSF  (Sargramostim) is used to enhance the immune response.

To determine the effectiveness of peptide vaccine therapy and/or GM-CSF in treating patients with locally advanced or metastatic melanoma.

December 1999

NCT00005034

Melanoma

Vaccine Therapy Compared With Interleukin-2 and/or  Chemotherapy in Treating Patients With Stage IV Melanoma

Heat Shock protein-
peptide Complex
(HSPCC-96)

Jonsson
Comprehensive
Cancer Center

Heat shock protein gp96 plus associated peptides is prepared from surgically removed melanoma tissue.

To compare the effectiveness of heat shock protein vaccine to IL-2 therapy and/or chemotherapeutic agents, dacarbazine and temozolomide.

October 2002

NCT00047359

Melanoma

A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma

Not Named

National
Cancer
Institute

The vaccine contains gp100, IL-2, and Montanide ISA-51.  Montanide ISA-51 is an oil used to enchance the immune response.

Since high dose IL-2 is currently approved by the FDA for treating patients with metastatic melanoma, the protocol will compare the use of  the vaccine plus IL-2 to L-2 alone.

February 1999

NCT00001801

Multiple Myeloma

Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation

Not Named

National
Cancer
Institute

Patient-derived vaccine consists of the myeloma immunoglobulin idiotype protein attached to KLH.  GM-CSF is used to enhance the immune response.

Bone marrow transplantation is used to treat multiple myeloma.  In one group, both the donor and recipient of bone marrow transplant are vaccinated with the patient-derived vaccine before transplantation.  This group is compared to one where only patients (recipients of transplant) receive the vaccine.  The goal is to see if the added immune boost to the donor can be transferred to the recipient to enhance the anti-tumor effect of the vaccine.

November 1996

NCT00001561

Prostate

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Northwest
Biotherapeutics

Cells from patient's blood (peripheral blood mononuclear cells) plus interleukin-4 and GM-CSF are used to generate dendritic cells, which are then treated with the adjuvant BCG and stimulated with prostate-specific membrane antigen.

To compare disease progression and survival in patients receiving dendritic vaccines to those receiving peripheral blood mononuclear cells.

November 2002

NCT00043056