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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 |
Biological: EGFR antisense DNA Biological: keyhole limpet hemocyanin Biological: sargramostim |
Phase I |
| 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 | |
| Study Chair: | Robert B. Montgomery, MD | Veterans Affairs Medical Center - Seattle |
More Information
| Study ID Numbers: | CDR0000068824, SWOG-S0114, UW-106, NCI-V01-1664 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00023634 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II gastric cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer adenocarcinoma of the prostate stage II ovarian epithelial cancer |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent adult brain tumor stage IV prostate cancer recurrent prostate cancer adult anaplastic astrocytoma |
|
Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Gonadal Disorders Urogenital Neoplasms Central Nervous System Neoplasms Ovarian Diseases Keyhole-limpet hemocyanin Genital Diseases, Female Stomach Diseases Stomach Neoplasms Ovarian Cancer Nervous System Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Astrocytoma Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Ovarian Epithelial Cancer Genital Diseases, Male Recurrence Brain Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Endocrinopathy Stomach Cancer Adenocarcinoma |
|
Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Central Nervous System Neoplasms Ovarian Diseases Keyhole-limpet hemocyanin Genital Diseases, Female Stomach Diseases Neoplasms by Site Stomach Neoplasms Nervous System Neoplasms |
Endocrine Gland Neoplasms Digestive System Neoplasms Ovarian Neoplasms Nervous System Diseases Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Genital Diseases, Male Pharmacologic Actions Adnexal Diseases Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Prostatic Neoplasms |