NCT00023634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_1

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

7.4 years

First QC Date

September 13, 2001

Last Update Submit

March 5, 2015

Conditions

Brain TumorsGastric CancerOvarian CancerProstate Cancer

Keywords

stage II gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric canceradenocarcinoma of the prostatestage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent adult brain tumorstage IV prostate cancerrecurrent prostate canceradult anaplastic astrocytoma

Outcome Measures

Primary Outcomes (1)

  • toxicity

    during treatment

Study Arms (2)

EGFR vaccine with GMCSF

EXPERIMENTAL

EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m

Biological: GMCSF

EGFR vaccine with KLH

EXPERIMENTAL

EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m

Biological: KLH

Interventions

KLHBIOLOGICAL

100 mcg w/EGFRvIII

Also known as: keyhole limpet
EGFR vaccine with KLH
GMCSFBIOLOGICAL

arm 1: 100 mcg w/EGFRvIII

Also known as: sargramostim
EGFR vaccine with GMCSF

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of one the following: * Stage II-IV gastric cancer * Stage IIC-IV ovarian cancer in first complete remission * CA 125 normal and stable\* * Grade III anaplastic astrocytoma * Stage IV (M1) prostate adenocarcinoma * No small cell variations * No biochemical progression after definitive surgery, defined by the following: * Prostate-specific antigen more than 0.4 ng/mL which remains elevated on 2 additional measurements at least 2 weeks apart after prostatectomy * Three consecutive rises in PSA, each at least 1 month apart after definitive radiotherapy * Must be receiving androgen blockade * PSA less than 5 ng/mL and stable\* * Documented EGFRvIII expression in primary tumor * Must have received prior surgery and or chemoradiotherapy for disease (except prostate cancer patients) NOTE: \*Stable defined as no increase over 2 measurements at least 28 days apart with the last measurement within the past 28 days PATIENT CHARACTERISTICS: Age: * 80 and under Performance status: * Zubrod 0 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * SGOT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * No hepatitis Renal: * Not specified Other: * No other malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission * No contraindication to receiving sargramostim (GM-CSF) or KLH-based vaccine products * No autoimmune disease * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 1 month since prior cytotoxic chemotherapy * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 1 month since prior treatment dose corticosteroids * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * Recovered from all prior therapies * No concurrent enrollment on other phase I studies * No other concurrent immune modulators

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98114, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Wenatchee Valley Clinic

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsStomach NeoplasmsOvarian NeoplasmsProstatic NeoplasmsCarcinoma, Ovarian EpithelialAstrocytoma

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Study Officials

  • Robert B. Montgomery, MD

    VA Puget Sound Health Care System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(13)