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

Prostate Cancer Clinical Trial

Official title:

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00023634
• Other study ID #: S0114
• Secondary ID: U10CA032102R01CA
• Status: Terminated
• Phase: Phase 1
• First received: September 13, 2001
• Last updated: March 5, 2015
• Start date: June 2001
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Gastric Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Stomach Neoplasms

Intervention

Biological:
• KLH
100 mcg w/EGFRvIII
• GMCSF
arm 1: 100 mcg w/EGFRvIII

Locations

Country	Name	City	State
United States	Bay Regional Medical Center	Bay City	Michigan
United States	St. Joseph Hospital Community Cancer Center	Bellingham	Washington
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Wenatchee Valley Clinic	Wenatchee	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity		during treatment	Yes