Clinical trial · Interventional
S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
NCT00023634CI-TRIAL-00017057terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GMCSF | Biological | — | UNRESOLVED |
| KLH | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EGFR vaccine with GMCSF
- description
- EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
- interventionNames
- Biological: GMCSF
- type
- EXPERIMENTAL
- label
- EGFR vaccine with KLH
- description
- EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m
- interventionNames
- Biological: KLH
Primary outcomes (1)
- measure
- toxicity
- timeFrame
- during treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 modulatorsReferences
Publications (0)
Data not yet available
No reference posted for this study.