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Brain TumorsPhase 1NCT00023634

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

A Phase 1 study testing KLH and GMCSF in people with Brain Tumors and Gastric Cancer, run by SWOG Cancer Research Network at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Brain Tumors, Gastric Cancer, Ovarian Cancer
What is being tested?
KLH and GMCSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
13 sitesUnited States
Study dates
Jun 2001to Nov 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
KLH, GMCSF
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
Medical subject headings
Brain Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Carcinoma, Ovarian Epithelial, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KLHBiological

    Also called keyhole limpet

    100 mcg w/EGFRvIII

  • GMCSFBiological

    Also called sargramostim

    arm 1: 100 mcg w/EGFRvIII

Study groups in NCT00023634
Study groupRoleWhat they receive
EGFR vaccine with GMCSFExperimentalEGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
Receives: Biological: GMCSF
EGFR vaccine with KLHExperimentalEGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m
Receives: Biological: KLH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. toxicity

    Measured: during treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2001
  3. Primary completionNov 2008
  4. Study completionNov 2008

Why it stopped: lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023634
Sponsor's protocol ID
S0114
Other IDs
U10CA032102, R01CA082661, S0114, UW-106
Status last verified
Mar 2015
First submitted
13 Sep 2001
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KLH and GMCSF in people with Brain Tumors and Gastric Cancer, run by SWOG Cancer Research Network at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: lack of accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

toxicity (time frame: during treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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