Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHER-2/neu peptide vaccine and sargramostim

The study team can explain what participation involves.

Who it may be forLocally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 30, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Washington

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Locally advanced→Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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.

Study sites

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.

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