A Phase I Trial of Dendritic Cell Vaccination With and Without Inhibition of Myeloid Derived Suppressor Cells by Gemcitabine Pre-Treatment For Children And Adults With Sarcoma

Inclusion Criteria:

- Age: 1 - 100 years old.

- Histologically or cytologically confirmed sarcoma either relapsed or without known
curative therapies. Both bone sarcomas and soft tissue sarcomas are eligible.
Osteosarcoma, chondrosarcoma, Ewing's sarcoma and any other diagnoses of sarcoma are
eligible as long as there is soft tissue that can be excised and be used to prepare
lysate. Subjects presenting only with lesions that are only comprised of bone are
excluded. Any number of prior therapies is allowed, including zero.

- No radiotherapy to other sites planned and/or other chemotherapy planned for the
study period. No radiotherapy or chemotherapy to have been received for at least 4
weeks before study entry. To allow for better local control without introducing undue
toxicity into the trial, brachytherapy at time of surgery scheduled to end by one
week before first vaccination is allowed. In the event of positive margins being
determined after surgical resection, but not determined in time for the placement of
brachytherapy catheters, external beam radiotherapy may start after the last DC
vaccination is administered but before the lysate boosts begin.

- No treatment with corticosteroids, antihistamines or salicylates for at least 1 week
before first vaccination.

- Adequate organ function (to be measured at enrollment)

- Absolute neutrophil count (ANC) >750/L

- Lymphocytes > 500/L

- Platelets > 75,000/L

- Hemoglobin > 9 g/dL

- AST/ALT < 2.5 X ULN; if liver metastases, < 5 X ULN

- Serum Creatinine < 1.5 X ULN

- Total Bilirubin < 3 X ULN

- Albumin > 2 g/dL

- ECOG performance status of 0 or 1

- Subjects must agree to use adequate method of contraception or abstinence throughout
and up to 4 weeks after the study treatment completion.

- Life expectancy of > 3 months.

- Capable of understanding the investigational nature, potential risks and benefits of
the study and able to provide valid informed consent.

- Written consent by patient or parent(s) (if patient is < 18 years) on an
institutional review board (IRB)-approved informed consent form prior to any
study-specific evaluation. Assent is required from children as per UM IRB
guidelines.

Exclusion Criteria:

- Pregnancy

- Breast feeding females.

- Any concomitant participation in other therapeutic trials

- Virus serology known to be positive for HIV (testing is not required in the absence
of clinical suspicion)

- Documented immunodeficiency

- Documented autoimmune disease

- Concomitant treatment with corticosteroids, antihistamines (H1 and H2 inhibitors) or
salicylates. Patients may be eligible if the treatment is stopped at least 1 week
before the first vaccination.

- Brain metastases unless they have been stable for 3 months off of treatment directed
specifically at them.

- Known allergy to gemcitabine or its formulation components. Intolerant to
gemcitabine

- Does not apply to cohorts to be treated without gemcitabine

- Prior therapy with gemcitabine is allowed on all cohorts

- Refusal to use adequate contraception for fertile patients (females and males) during
the study and for 30 days after the last dose of study treatment.

- Any serious or uncontrolled medical or psychiatric condition that in the opinion of
the investigator makes the patient not able to participate in the study.