Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors (NCT00019331) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
United StatesStarted 1997-10
Plain-language summary
RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma
* Ras mutations must be one of the following point mutations at codon 12:
* Glycine to cysteine
* Glycine to aspartic acid
* Glycine to valine
* Metastatic disease for which no known chemotherapy or radiotherapy would increase survival
* Tumor tissue must be available for determination of ras mutation
* No prior CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 4 times normal
* No hepatitis B or C infection
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No active ischemic heart disease (New York Heart Association class III or IV)
* No myocardial infarction within the past 6 months
* No history of congestive heart failure, ventricular arrhythmias, or other arrhythmias requiring therapy
Immunologic:
* No prior allergy to eggs
* No prior autoimmune disease, including the following:
* Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
* Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma
* Myasthenia gravis
* Goodpasture syndrome
* Addison's disease, Hashimoto's thyr…