S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer

Phase 1

Terminated

• Conditions: Prostate Cancer; Gastric Cancer; Brain Tumors; Ovarian Cancer
• Interventions: Biological: GMCSF; Biological: KLH

• Registration Number: NCT00023634
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill cancer cells.

PURPOSE: This phase I trial is studying two different vaccines to treat patients who have gastric, prostate, or ovarian cancer.

Detailed Description

OBJECTIVES:

* Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.

* Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.

* Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.

OUTLINE: Patients are assigned to one of two treatment arms.

* Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.

* Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly.

Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGFR vaccine with GMCSF	GMCSF	EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
EGFR vaccine with KLH	KLH	EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m

Primary Outcome Measures

Name	Time	Method
toxicity	during treatment

Trial Locations

Locations (13)

St. Joseph Hospital Community Cancer Center; 🇺🇸 Bellingham, Washington, United States

Olympic Hematology and Oncology; 🇺🇸 Bremerton, Washington, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Skagit Valley Hospital Cancer Care Center; 🇺🇸 Mt. Vernon, Washington, United States

Group Health Central Hospital; 🇺🇸 Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Cancer Care Northwest - Spokane South; 🇺🇸 Spokane, Washington, United States

North Puget Oncology at United General Hospital; 🇺🇸 Sedro-Wooley, Washington, United States

Wenatchee Valley Clinic; 🇺🇸 Wenatchee, Washington, United States

Mercy Regional Cancer Center at Mercy Hospital; 🇺🇸 Port Huron, Michigan, United States

Bay Regional Medical Center; 🇺🇸 Bay City, Michigan, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus; 🇺🇸 Seattle, Washington, United States