S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
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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 Tumors Gastric Cancer Ovarian Cancer Prostate Cancer |
Biological: KLH Biological: GMCSF |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers |
- toxicity [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | June 2001 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EGFR vaccine with GMCSF
EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
|
Biological: GMCSF
arm 1: 100 mcg w/EGFRvIII
Other Name: sargramostim
|
|
Experimental: EGFR vaccine with KLH
EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m
|
Biological: KLH
100 mcg w/EGFRvIII
Other Name: keyhole limpet
|
Detailed Description:
OBJECTIVES:
- Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.
- Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.
- Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.
OUTLINE: Patients are assigned to one of two treatment arms.
- Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.
- Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly.
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: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| 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 | |
| North Puget Oncology at United General Hospital | |
| Sedro-Wooley, Washington, United States, 98284 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| Study Chair: | Robert B. Montgomery, MD | Department of Veterans Affairs |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00023634 History of Changes |
| Other Study ID Numbers: | CDR0000068824, U10CA032102, R01CA082661, S0114, UW-106 |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Stomach Neoplasms Ovarian Neoplasms Prostatic Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Stomach Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013