Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
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
1 other identifier
interventional
12
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2005
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 23, 2005
CompletedFirst Posted
Study publicly available on registry
November 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 3, 2021
March 1, 2021
1.5 years
November 23, 2005
March 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Years
Secondary Outcomes (1)
To determine the disease response, immune response, and overall survival rate
Study Arms (2)
Treatment Arm A
EXPERIMENTALGVAX for Sarcoma / Renal Cell Patients
Treatment Arm B
EXPERIMENTALGVAX for Pediatric Melanoma Patients
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Boston Children's Hospitalcollaborator
Study Sites (2)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (2)
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. doi: 10.1200/JCO.2003.07.005.
PMID: 12947071BACKGROUNDSalgia 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. doi: 10.1200/JCO.2003.03.091.
PMID: 12586798BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 23, 2005
First Posted
November 28, 2005
Study Start
January 1, 2005
Primary Completion
July 1, 2006
Study Completion
December 1, 2020
Last Updated
March 3, 2021
Record last verified: 2021-03