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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| R01CA082661 | U.S. NIH Grant/Contract | View source | |
| S0114 | Other Identifier | SWOG | |
| UW-106 | Other Identifier | University of Washington |
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lack of accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: Patients are assigned to one of two treatment arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR vaccine with GMCSF | Experimental | EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m |
|
| EGFR vaccine with KLH | Experimental | EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLH | Biological | 100 mcg w/EGFRvIII |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| toxicity | during treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one the following:
Stage II-IV gastric cancer
Stage IIC-IV ovarian cancer in first complete remission
Grade III anaplastic astrocytoma
Stage IV (M1) prostate adenocarcinoma
No small cell variations
No biochemical progression after definitive surgery, defined by the following:
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Robert B. Montgomery, MD | VA Puget Sound Health Care System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Regional Medical Center | Bay City | Michigan | 48708 | United States | ||
| Mercy Regional Cancer Center at Mercy Hospital |
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| GMCSF | Biological | arm 1: 100 mcg w/EGFRvIII |
|
|
| Port Huron |
| Michigan |
| 48060 |
| United States |
| St. Joseph Hospital Community Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | 98273 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98114 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| North Puget Oncology at United General Hospital | Sedro-Woolley | Washington | 98284 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Wenatchee Valley Clinic | Wenatchee | Washington | 98801 | United States |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D013274 | Stomach Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C081222 | sargramostim |
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