Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma … (NCT00258687) | Clinical Trial Compass
CompletedPhase 1
Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
United States12 participantsStarted 2005-01
Plain-language summary
The purpose of this study is to learn if a vaccine made from the patient's own tumor cells, then genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's effects on the immune system and the side effects of giving a vaccine made from a subject's own cancer cells.
Who can participate
SexALL
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Inclusion Criteria:
* ECOG performance status 0 or 1
* Estimated life expectancy of greater than 6 months
* Greater than or equal to 4 weeks from chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy
* Greater than or equal to 6 months from prior bone marrow or peripheral blood stem cell (PBSC) transplant
* Histologically confirmed alveolar soft part sarcoma or clear cell sarcoma at any age.
* Evidence of metastatic disease, including having spread either to distant sites that may include brain metastases, or to regional lymph nodes alone, or locally advanced primary lesion that is not fully surgically resectable at study entry.
* Histologically confirmed Stage IV renal cell carcinoma (patients with brain metastases still eligible)
* Any patients with Stage IV renal cell carcinoma under the age of 25 years who do not have a renal cell carcinoma predisposition syndrome
* Patients with Stage IV melanoma and under the age of 18 years
Exclusion Criteria:
* Uncontrolled active infection
* Pregnancy or nursing mothers
* Infection with HIV, hepatitis B or hepatitis C
* Any other significant medical, surgical, or psychiatric condition that may interfere with compliance with protocol regimen
* Other current malignancies apart from any in situ cancer or basal or squamous cell carcinoma
* Pediatric melanoma only: infants with transplacentally acquired melanoma; or children with brain metastases and malignant melanoma.
What they're measuring
1
To determine the safety and feasibility of preparation and administration of vaccine in patients with metastatic or locally advanced clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and translocation associated renal cell carcinoma (RCC)