Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Stopped early · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors
Key facts
- Study ID
- NCT00030693
- Run by
- National Cancer Institute (NCI)
- People needed
- 42
- Starts
- 2001-12-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed metastatic unresectable solid tumors
- Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
- No standard therapy available
- At least 1 unidimensionally measurable lesion
- At least 20 mm for visceral lesions
- At least 10 mm for cutaneous, subcutaneous, and nodal lesions
- No untreated or edematous metastatic brain lesions
- At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
- No ascites or pleural effusions
- No leptomeningeal disease
- Performance status - ECOG 0-1
- More than 3 months
- Absolute granulocyte count at least 3,000/mm\^3
- Platelet count at least 100,000/mm\^3
- No bleeding diathesis
- Bilirubin no greater than 1.5 mg/dL*
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
- Alkaline phosphatase no greater than 2 times ULN*
- No elevated PT or PTT
- No cirrhosis
- No active hepatitis
- No hepatic insufficiency
- Creatinine no greater than 2.0 mg/dL
- No renal insufficiency
- No chronic obstructive pulmonary disorder
Where it is running
- Mount Sinai Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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