Phase II Clinical Trial
Dendritic Cell Vaccine Therapy of
Sarcoma Patients Post Stem Cell Transplantation

ABSTRACT

Children and young adults with metastatic or recurrent soft tissue sarcomas have a dismal prognosis despite aggressive multi-modal therapies. Although high dose chemotherapy with autologous hematopoietic stem cell transplant (HSCT) effectively reduces the tumor burden in the majority of pediatric and young adult patients with high-risk sarcomas, relapse following this approach remains the major problem and new therapies for control of minimal residual disease (MRD) are needed. Immunotherapy strategies, specifically dendritic cell (DC) based tumor vaccines, against solid tumors have been shown in pre-clinical and early clinical trials to be safe and produce anti-tumor responses in adults and children. Recent experimental evidence indicates that the period of lymphopenia that occurs after HSCT may be an opportune time to improve the immune response to self tumor antigens. Therefore, consolidation of MRD following autologous HSCT with a DC based tumor vaccine represents a logical and attractive approach for the treatment of sarcoma patients.

The Pediatric Blood and Marrow Transplant Consortium has already studied a conditioning regimen of high dose chemotherapy followed by autologous HSCT in pediatric and young adult patients with soft tissue sarcomas (PBMTC protocol-ONC9616). Using this experience as a foundation, patients in the proposed trial will receive an identical conditioning regimen and HSCT followed by a series of three autologous monocyte-derived tumor lysate-pulsed mature DC vaccines. Patients will be assessed for both clinical response and specific immunologic anti-tumor response by ELISPOT and other immunoassays.

Specific Aims:

1. To determine if tumor lysate-pulsed DC vaccine early after autologous HSCT can prolong progression-free survival (PFS) in pediatric and young adult patients with sarcoma.

2. To evaluate the ability of tumor lysate-pulsed DC vaccine to augment the anti-tumor immune response in pediatric and young adult patients with sarcomas after autologous HSCT.

The proposed studies will further our understanding of immune responses to sarcomas and the ability of DC tumor vaccine to modulate the anti-tumor immune response in the post-HSCT lymphopenic environment.

IF YOU ARE A RECURRENT/RELAPSE EWING'S SARCOMA PATIENT AND WANT MORE INFORMATION ABOUT THIS VACCINE, THE PHASE II CLINICAL TRIAL OR THE "PILOT STUDY" SEE BELOW:

PLEASE CALL:

DR. JAMES D. GEIGER, LEAD INVESTIGATOR
Tumor Immunologist and Pediatric Surgeon
Associate Professor
University of Michigan Medical School
Mott Children's Hospital
(734) 763-2072

OR

THE BRIAN MORDEN FOUNDATION
(800) 997-7278

Important additional Information:

THE PILOT  STUDY

If you are a patient who is seriously ill with ES or a parent of a child who is very sick with ES, please note the following.  

The National Institutes of Health/National Cancer Institute review process will normally take six to eight months.  A decision to fund this Phase II ES Vaccine Clinical Trial may not come until August '04.  This means that many of the critical patients whose cancer has returned (recurred) won't make it through the review period.     

Dr. Geiger and his research team will open a "Pilot Study" program that is privately funded to allow ES patients in dire need to receive treatment much sooner.  Under a Pilot Study, patients can be treated on an as-needed-basis.  The
NIH/NCI proposal depends on public dollars and restricts the treatment period and use of the vaccine.  A privately funded "Pilot Study" would allow for adaptations.  

THIS ANNOUNCEMENT IS ONLY INTENDED TO BE INFORMATIONAL IN NATURE AND NOT MEDICAL ADVICE. IN ALL CASES, YOUR ONCOLOGIST AND DR. GEIGER OR A MEMBER OF HIS TEAM MUST DISCUSS YOUR PARTICULAR CASE IN ORDER TO DETERMINE IF THIS TREATMENT IS RIGHT FOR THE PATIENT.

Cancer Research by Dr. Geiger and colleagues:

A Phase I Trial of Tumor Lysate-pulsed Dendritic Cells in the Treatment of Advanced Cancer - published in Clinical Cancer Research, April 2002 (pdf file)

Vaccination Of Pediatric Solid Tumor Patients with Tumor Lysate-pulsed Dendritic Cells Can Expand Specific T Cells and Mediate Tumor Regression - published in Cancer Research, December 1, 2001 (pdf file)

 

If you're interested in financially supporting the vaccine pilot study, please contact us.

return to brianmordenfoundation.org <3
Contact The Brian Morden Foundation at fdj@brianmordenfoundation.org