Clinical trial · Interventional
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
NCT00258687CI-TRIAL-00050445completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Sarcoma, Alveolar Soft Part | Alveolar Soft Part Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma, Clear Cell | Clear Cell Sarcoma of Soft Tissue | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GVAX | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm A
- description
- GVAX for Sarcoma / Renal Cell Patients
- interventionNames
- Biological: GVAX
- type
- EXPERIMENTAL
- label
- Treatment Arm B
- description
- GVAX for Pediatric Melanoma Patients
- interventionNames
- Biological: GVAX
Primary outcomes (1)
- measure
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDSoiffer 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 12947071
- BACKGROUNDSalgia 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 12586798