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 range18 Years
SexALL
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…
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