Status:
COMPLETED
Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Sarcoma, Clear Cell
Sarcoma, Alveolar Soft Part
Eligibility:
All Genders
Phase:
PHASE1
Brief 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 o...
Detailed Description
The patient will have surgery to remove a portion of the tumor. This tumor is then brought to a special, certified laboratory where it is broken up into single cells and then washed. Specially traine...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00258687
Start Date
January 1 2005
End Date
December 1 2020
Last Update
March 3 2021
Active Locations (2)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115