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S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer

Primary Purpose

Brain Tumors, Gastric Cancer, Ovarian Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KLH
GMCSF
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bay Regional Medical Center
  • Mercy Regional Cancer Center at Mercy Hospital
  • St. Joseph Hospital Community Cancer Center
  • Olympic Hematology and Oncology
  • Skagit Valley Hospital Cancer Care Center
  • Fred Hutchinson Cancer Research Center
  • Harborview Medical Center
  • Group Health Central Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • University Cancer Center at University of Washington Medical Center
  • North Puget Oncology at United General Hospital
  • Cancer Care Northwest - Spokane South
  • Wenatchee Valley Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EGFR vaccine with GMCSF

EGFR vaccine with KLH

Arm Description

EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m

EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m

Outcomes

Primary Outcome Measures

toxicity

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
March 5, 2015
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00023634
Brief Title
S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer
Official Title
An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
lack of accrual
Study Start Date
June 2001 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors, Gastric Cancer, Ovarian Cancer, Prostate Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGFR vaccine with GMCSF
Arm Type
Experimental
Arm Description
EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
Arm Title
EGFR vaccine with KLH
Arm Type
Experimental
Arm Description
EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m
Intervention Type
Biological
Intervention Name(s)
KLH
Other Intervention Name(s)
keyhole limpet
Intervention Description
100 mcg w/EGFRvIII
Intervention Type
Biological
Intervention Name(s)
GMCSF
Other Intervention Name(s)
sargramostim
Intervention Description
arm 1: 100 mcg w/EGFRvIII
Primary Outcome Measure Information:
Title
toxicity
Time Frame
during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B. Montgomery, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Study Chair
Facility Information:
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
St. Joseph Hospital Community Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mt. Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98114
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
North Puget Oncology at United General Hospital
City
Sedro-Wooley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer

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