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

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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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

toxicity


Condition

Brain Tumors

Intervention

KLH

Study Arms / Comparison Groups

 EGFR vaccine with GMCSF
Description:  EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

14

Start Date

June 2001

Completion Date

November 2008

Primary Completion Date

November 2008

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Robert B. Montgomery, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00023634

Organization ID

S0114

Secondary IDs

U10CA032102

Responsible Party

Sponsor

Study Sponsor

Southwest Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Robert B. Montgomery, MD, Study Chair, VA Puget Sound Health Care System


Verification Date

March 2015