Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer (NCT00028496) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
United States48 participantsStarted 2001-11
Plain-language summary
Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more 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:
* Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks
* Advanced or metastatic disease
* Recurrent or unresectable disease
* Microscopic metastatic disease confirmed by surgical exploration allowed
* CEA expression by immunohistochemistry
* Circulating CEA greater than 5 ng/mL
* HLA phenotyping required
* HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation
* No clinically symptomatic brain metastases
* Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible
* Hormone receptor status:
* Not specified
* Male or female
* Performance status - ECOG 0-1
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST and ALT less than 3 times ULN
* PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated)
* Creatinine less than 1.5 mg/dL
* Creatinine clearance greater than 60 mL/min
* Proteinuria or hematuria less than +2 on urinalysis\*
* Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1
* No frequent vomiting or severe anorexia
* No more than 10% weight loss within the past 3 months
* No inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
* No uncontrolled seizure disorder…
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
Maximum tolerated dose of recombinant fowlpox-CEA(6D)/TRICOM vaccine determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria, version 2.0