Vaccine Therapy in Treating Patients With Metastatic Solid Tumors (NCT01376505) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
United States65 participantsStarted 2011-06-21
Plain-language summary
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have histologically confirmed metastatic solid tumor; the malignancy should be considered incurable using standard treatment
* Patients are not required to have HER-2 over-expression to be on this study
* If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted
* If the patient has not had HER-2 expression measured prior to enrollment on this study tumor tissue blocks and/or freshly isolated tissue must be available for determination of HER-2 expression
* Patients are not required to have epidermal growth factor receptor (EGFR) over-expression to be on this study
* If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted
* If the patient has not had EGFR expression measured prior to enrollment on this study tumor tissue blocks and/or freshly isolated tissue must be available for determination of EGFR expression
* Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible
* Patients must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* White blood cells \> 3500/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum bilirubin \< 1.5 mg %, regardless of whether patients have liver involvement secondary to tumor
* Alanine aminotransferase (ALT) must be \< 2 times upper limit of normal
* Creatinine \< 1.5 mg/dL or caā¦
What they're measuring
1
Type and duration of immune response measured over time to repeat vaccine administration