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 range
18 Years
Sex
ALL
See this in plain English?
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 ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type and duration of immune response measured over time to repeat vaccine administration