Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00023634
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00023634
Study Brief:
Protocol Section:
NCT00023634