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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023634 |
Purpose
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.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors Gastric Cancer Ovarian Cancer Prostate Cancer |
Drug: EGFR antisense DNA Drug: keyhole limpet hemocyanin Drug: sargramostim |
Phase I |
| MedlinePlus related topics: | Cancer Ovarian Cancer Prostate Cancer Stomach Cancer |
| Drug Information available for: | Sargramostim Granulocyte-macrophage colony-stimulating factor |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers |
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2001 |
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.
Eligibility
| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one the following:
Stage IIC-IV ovarian cancer in first complete remission
Stage IV (M1) prostate adenocarcinoma
No biochemical progression after definitive surgery, defined by the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Michigan | |||||
| Bay Regional Medical Center | |||||
| Bay City, Michigan, United States, 48708 | |||||
| Mercy Regional Cancer Center at Mercy Hospital | |||||
| Port Huron, Michigan, United States, 48060 | |||||
| United States, Washington | |||||
| Cancer Care Northwest - Spokane South | |||||
| Spokane, Washington, United States, 99202 | |||||
| Fred Hutchinson Cancer Research Center | |||||
| Seattle, Washington, United States, 98104 | |||||
| Group Health Central Hospital | |||||
| Seattle, Washington, United States, 98112 | |||||
| Harborview Medical Center | |||||
| Seattle, Washington, United States, 98104 | |||||
| Wenatchee Valley Clinic | |||||
| Wenatchee, Washington, United States, 98801 | |||||
| Olympic Hematology and Oncology | |||||
| Bremerton, Washington, United States, 98310 | |||||
| Skagit Valley Hospital Cancer Care Center | |||||
| Mt. Vernon, Washington, United States, 98273 | |||||
| St. Joseph Hospital Community Cancer Center | |||||
| Bellingham, Washington, United States, 98225 | |||||
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |||||
| Seattle, Washington, United States, 98114 | |||||
| University Cancer Center at University of Washington Medical Center | |||||
| Seattle, Washington, United States, 98195-6043 | |||||
| North Puget Oncology at United General Hospital | |||||
| Sedro-Wooley, Washington, United States, 98284 | |||||
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Robert B. Montgomery, MD | Veterans Affairs Medical Center - Seattle |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068824, SWOG-S0114, UW-106, NCI-V01-1664 |
| First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00023634 |
| Health Authority: | United States: Federal Government |
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