Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
Completed · Phase 1
Conditions studied: Sarcoma, Clear Cell, Sarcoma, Alveolar Soft Part, Renal Cell Carcinoma, Melanoma
In brief
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.
Key facts
- Study ID
- NCT00258687
- Run by
- Dana-Farber Cancer Institute
- People needed
- 12
- Starts
- 2005-01-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2021-03-03
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.