Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
RATIONALE: Vaccines may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer.
Checked against the public recordLast updated Nov 30, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Washington
- Interventions being studied
- Biological: HER-2/neu peptide vaccine; Biological: sargramostim
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: Stage III adenocarcinoma that overexpresses HER-2 and previously treated by surgical resection, conventional chemotherapy, or radiotherapy OR Stage IV adenocarcinoma that overexpresses HER-2 and in stable or complete remission with no other concurrent chemotherapy Must have documented HER-2 protein overexpression in the primary or metastatic tumor HLA-A2 positive PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 90-100% Life expectancy: At least 12 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Female patients must have completed childbearing Fertile male patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior corticosteroids Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No other concurrent investigational phase I studies
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Washington School of MedicineSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 30, 2017. Always confirm current availability with the study team.