A Pilot Study of Tumor Lysate-pulsed Dendritic Cell Vaccine for Immune Augmentation for High-risk Solid Tumor Patients Following Autologous Stem Cell Transplantation

Eligibility

Inclusion Criteria:

To participate in this study, it is necessary to collect sufficient tumor and peripheral
blood stem cells to both develop the vaccine and perform the autologous stem cell
transplant. Patients who also have previously had tumor or stem cells collected, which are
available and sufficient for this study, are eligible to participate as study subjects.

1. Patients must have a histologically verified diagnosis of neuroblastoma, Wilm's
tumor, or sarcoma, including rhabdomyosarcoma, a Ewing's sarcoma family tumor (ES,
PNET), synovial sarcoma, fibrosarcoma, or desmoplastic round cell tumor.

and must meet one of the following criteria:

1. have metastatic disease at diagnosis

2. have never achieved complete remission following frontline standard therapy

3. have relapsed after receiving standard therapy

2. Patients must have been < 30 years of age at the time of original diagnosis.

3. Patients must have a source of tumor tissue from which approximately 1 gram of viable
tumor can be obtained for vaccine development.

4. Patients must have a good performance status (>70% by Lansky or Karnofsky
scales).

5. Patients must have a life expectancy of at least 16 weeks.

6. Females of child-bearing age (>= 12 years old) must have a negative pregnancy test.

Patients may enroll on this study at various points in their treatment including
diagnosis, recurrence, or just prior to initiation of study mandated transplant
therapy. Because patients may enter this study prior to completion of retransplant
treatments, the below criteria must be met only to proceed to the high dose
chemotherapy and autologous stem cell transplant part of this study. These criteria
are not a requirement to enter this study in order to collect tumor or peripheral
blood stem cells.

7. Patients must have achieved complete response or very good partial response(>= 90%
decrease in tumor volume) before proceeding to transplant. For patients enrolling on
this study just prior to transplant a VGPR or CR must be achieved to be eligible.

8. Patients may have undergone prior autologous peripheral blood stem cell
transplantation, provided at least 12 months have elapsed prior to entry on this
study.

9. Patients must have had a successful peripheral blood stem cell collection, with
cryopreservation of PBSCs for both engraftment and for generation of dendritic cells.

10. Adequate baseline organ function must be present:

hematologic parameters (not applicable if bone marrow is involved with tumor):

1. ANC > 500/mm3

2. platelet count > 50,000/mm3

3. serum creatinine < 1.5x upper limit of normal for age

4. serum hepatic transaminases (AST, ALT) < 3x upper limit of normal

5. serum bilirubin < 1.5x upper limit of normal

6. cardiac echocardiogram with either SF > 27% or EF > 50%. A comparable EF on a
MUGA scan will also meet eligibility criteria.

11. Give or obtain informed consent

Exclusion Criteria:

1. Patients who have received prior antitumor vaccines are ineligible

2. Patients who meet the response criteria but progress prior to study enrollment are
ineligible

3. Patients with known autoimmune diseases or conditions are ineligible

4. Patients with HIV infection, AIDS, hepatitis B surface antigen positivity, ongoing
bleeding, or any significant uncontrolled medical or psychiatric illness are
ineligible.

5. Patients under treatment for infection must cleared by BMT physician prior to
enrollment.

6. Patients who are pregnant or nursing are ineligible

7. Prior allogenic transplant