Melanoma Clinical Trial
Official title:
A Phase I Trial of Vaccination With Autologous, Lethally Irradiated Tumor Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Pediatric and Adult Patients
NCT number | NCT00258687 |
Other study ID # | 05-115 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2005 |
Est. completion date | December 2020 |
Verified date | March 2021 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2020 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Boston Children's Hospital |
United States,
Salgia R, Lynch T, Skarin A, Lucca J, Lynch C, Jung K, Hodi FS, Jaklitsch M, Mentzer S, Swanson S, Lukanich J, Bueno R, Wain J, Mathisen D, Wright C, Fidias P, Donahue D, Clift S, Hardy S, Neuberg D, Mulligan R, Webb I, Sugarbaker D, Mihm M, Dranoff G. Vaccination with irradiated autologous tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor augments antitumor immunity in some patients with metastatic non-small-cell lung carcinoma. J Clin Oncol. 2003 Feb 15;21(4):624-30. — View Citation
Soiffer R, Hodi FS, Haluska F, Jung K, Gillessen S, Singer S, Tanabe K, Duda R, Mentzer S, Jaklitsch M, Bueno R, Clift S, Hardy S, Neuberg D, Mulligan R, Webb I, Mihm M, Dranoff G. Vaccination with irradiated, autologous melanoma cells engineered to secrete granulocyte-macrophage colony-stimulating factor by adenoviral-mediated gene transfer augments antitumor immunity in patients with metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3343-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Years | ||
Secondary | To determine the disease response, immune response, and overall survival rate |
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