Prostate CancerPhase 1NCT00924092
An Open Label Phase I Study to Eval the Safety and Tolerability of a Vaccine (GI-6207) Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-expressing ...
A Phase 1 study testing GI-6207 [Recombinant Saccharomyces Cerevisia and (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)]) in people with Prostate Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Objectives: To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects. To see if GI-6207 has any effect on patients tumors. To learn how the vaccine causes immune responses against the cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Lung Cancer
- What is being tested?
- GI-6207 [Recombinant Saccharomyces Cerevisia and (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)])
- Type of treatment
- Vaccines
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2009to 2 Aug 2012
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed carcinoma by the NIH Laboratory of Pathology that has been shown to express CEA (either a CEA serum level > 5 microg/L or a tumor that stains positive for CEA in > 20% of a tumor block).
- Completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be a candidate for therapy of proven efficacy for their disease.
- 18 years of age or greater.
- Must have metastatic disease that is measurable or non-measurable but evaluable (e.g., pleural effusion or present on bone scan).
- Ability to understand and the willingness to sign a written informed consent document.
- ECOG performance status of 0 2 (Karnofsky greater than or equal to 50).
Show all 22Show fewer
- Serum creatinine less than or equal to 1.5 times upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min.
- ALT and AST less than or equal to 2.5 times the upper limits of normal.
- Total bilirubin less than or equal to 1.5 times upper limit of normal OR in patients with Gilbert s syndrome, a total bilirubin less than or equal to 3.0.
- Recovered completely from any reversible toxicity associated with recent therapy. Typically this is 3 4 weeks for patients who most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery. There should be a minimum of 2 weeks from any prior chemotherapy, immunotherapy and/or radiation.
- Hematological eligibility parameters (within 16 days of starting therapy):
- Granulocyte count greater than or equal to 1,500/mm(3)
- Platelet count greater than or equal to 100,000/mm(3)
- Prior immune therapy (e.g. related vaccinia and fowlpox vaccines or antigen-specific peptides) is allowed.
- Men and women must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy.
- Patients with prostate cancer must continue to receive GnRH agonist therapy (unless orchiectomy has been done).
- Patients must be negative for yeast allergy skin test.
- Patients must have baseline pulse oximetry greater than 90% on room air.
- INCLUSION CRITERIA (EXTENSION PHASE: 10 ADDITIONAL PATIENTS AT HIGHEST TESTED DOSE/MTD):
- Eligibility: Same as with the dose escalation phase with the following exceptions:
- Patients must be HLA-A2, A3, or A24 positive for immunologic monitoring.
- ECOG PS equal to 0 1.
Who cannot join
- Patients should have no evidence of immune dysfunction as listed below.
- Human immunodeficiency virus positivity due to the potential for decreased immune response to the vaccine.
- Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. Patients with endocrine autoimmune disease that is controlled by replacement therapy, including thyroid disease and adrenal disease; or those with vitiligo, may be enrolled.
- Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids to prevent IV contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed.
- History of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded).
- Pregnant or breast-feeding women.
Show all 11Show fewer
- Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
- Untreated brain metastases (or local treatment of brain metastases within the last 6 months) due to the poor prognosis of these patients and difficulty ascertaining the cause of neurologic toxicities.
- Concurrent chemotherapy. An exception is to allow for patients on the extension phase only with breast cancer who are receiving trastuzumab to continue therapy with trastuzumab while receiving the vaccine treatment.
- Chronic hepatitis infection, including B and C, because of potential immune impairment.
- Patients requiring continuous tricyclic antidepressant therapy should be excluded due to the interference with the yeast skin test in creating false negative test results.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Open Label Phase I Study to Evaluate the Safety and Tolerability of Vaccine (GI-6207) Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-Expressing Carcinoma
Objectives:
- To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects.
- To see if GI-6207 has any effect on patients tumors.
- To learn how the vaccine causes immune responses against the cancer.
Read more
Eligibility:
- Patients 18 years of age and older who have been diagnosed with a cancer that has not responded to standard treatments. Patients must not be allergic to yeast or yeast products.
Design:
- Initial physical examination, blood and tissue sampling, computed tomography (CT) scan, and skin test to determine eligibility for the procedure.
- Treatment with GI-6027 in seven 14-day cycles as follows:
- Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85.
- Vaccine given at four sites around the body: right and left chest area below the armpit, and right and left upper thigh in the pelvic region. (These areas drain into parts of your body that contain large numbers of lymph nodes. The lymph nodes contain immune cells that may be activated by the vaccine to target cancer cells.)
- Clinic visits for physical examinations to check vital signs, take additional blood and urine samples, and perform other tests needed for the study.
- After day 85 (about 3 months), patients will continue to receive vaccine monthly (or every 28 days) as long as the vaccine is not producing harmful effects or side effects and the cancer is either stable or reducing. Patients who do well on the vaccine may continue to receive it for as long as it is available.
Read the detailed description
Background:
Carcinoembryonic antigen (CEA) is overexpressed in multiple adenocarcinomas.
Previous clinical studies utilizing CEA-based vaccine therapy have demonstrated safety, T-cell immune responses against CEA, and preliminary evidence of clinical benefit.
Preclinical studies have shown that Saccharomyces-CEA (yeast-CEA) can induce a strong immune response to CEA as well as therapeutic antitumor responses in a CEA-transgenic host.
Previous and ongoing clinical studies utilizing whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express mutated Ras (GI-4000) or hepatitis C (GI-5005) proteins demonstrated this vaccine vehicle to be well tolerated, with no product-related serious adverse events in >200 treated subjects.
Objectives:
Primary
-To determine the safety and tolerability of escalating doses of a heat-killed yeast-based vaccine that targets tumors that express CEA.
Secondary
- To evaluate CD4 and CD8 immunologic response as measured by an increase in CEA-specific T cells measured by ELISPOT in HLA-A2, -A3 and -A24(+) patients, and proliferation in response to CEA protein.
- To evaluate evidence of clinical benefit, such as progression-free survival, RECIST criteria, reduction in serum markers, and/or reduction in circulating tumor cells.
Eligibility: (dose escalation phase)
Must have metastatic cancer that is CEA-positive (either a CEA serum level > 5 ng/mL or a tumor that stains positive for CEA in > 20% of a tumor block).
Must have completed or had disease progression on at least one prior line of disease-appropriate therapy, or not be a candidate for therapy of proven efficacy for their disease.
Must be ECOG Performance Status 0 2.
Should have no autoimmune diseases; no evidence of immune dysfunction; no serious intercurrent medical illness;
No untreated brain metastasis (or local treatment of brain metastases within the last 6 months)
Any hypersensitivity reaction to yeast-based products.
Eligibility: (extension phase: 10 additional patients at highest tested dose/MTD)
Same as for the dose escalation phase with the following exceptions:
- Patients must be HLA-A2, -A3, or -A24(+) for immunologic monitoring
- ECOG PS = 0 1
Design:
This is an open label, phase I trial with sequential cohorts of patients (3-6 patients per dose cohort) with dose escalation of heat-killed GI-6207 vaccine (see statistical analysis section).
GI 6207 vaccine will be administered subcutaneously at 4 sites biweekly for 7 visits (days 1, 15, 29, 43, 57, 71, 85), then monthly until patients meet off-study criteria.
All patients on a given dose level will have completed 1 month on-study before enrollment can begin on the next dose level or on the extension phase (see statistical analysis section).
- Being tested
- GI-6207 [Recombinant Saccharomyces Cerevisia, (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)])
- Keywords
- Immunotherapy, Lung Cancer, Colorectal Cancer, Head and Neck Cancer, Prostate, Breast Cancer
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-6207 [Recombinant Saccharomyces CerevisiaBiological
(Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)])Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of escalating doses of a heated-killed yeast-based vaccine that targets tumors that express CEA.
Secondary outcomes (1)
To evaluate CD4 and CD8 immunologic response. To evaluate humoral immune response to yeast antigen. To evaluate evidence of clinical benefit such as PFS, OR, & decreases in circulating tumor cells & tumor markers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start13 Mar 2009
- Study completion2 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ravi A Madan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924092
- Sponsor's protocol ID
- 090101
- Other IDs
- 09-C-0101
- Status last verified
- 20 May 2014
- First submitted
- 17 Jun 2009
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Robbins PF, Eggensperger D, Qi CF, Schlom J. Definition of the expression of the human carcinoembryonic antigen and non-specific cross-reacting antigen in human breast and lung carcinomas. Int J Cancer. 1993 Apr 1;53(6):892-7. doi: 10.1002/ijc.2910530604.
PubMed 8386136Kass ES, Greiner JW, Kantor JA, Tsang KY, Guadagni F, Chen Z, Clark B, De Pascalis R, Schlom J, Van Waes C. Carcinoembryonic antigen as a target for specific antitumor immunotherapy of head and neck cancer. Cancer Res. 2002 Sep 1;62(17):5049-57.
PubMed 12208760Hodge JW, Tsang KY, Poole DJ, Schlom J. General keynote: vaccine strategies for the therapy of ovarian cancer. Gynecol Oncol. 2003 Jan;88(1 Pt 2):S97-104; discussion S110-3. doi: 10.1006/gyno.2002.6694. No abstract available.
PubMed 12586096
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase I Study to Evaluate the Safety and Tolerability of Vaccine (GI-6207) Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-Expressing Carcinoma
- ClinicalTrials.gov ID
- NCT00924092
- Acronym / sponsor ID
- 090101
- Keywords
- Immunotherapy, Lung Cancer, Colorectal Cancer, Head and Neck Cancer, Prostate, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Mar 2009
- Study completion
- 2 Aug 2012 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects.
- To see if GI-6207 has any effect on patients tumors.
- To learn how the vaccine causes immune responses against the cancer.
Eligibility:
- Patients 18 years of age and older who have been diagnosed with a cancer that has not responded to standard treatments. Patients must not be allergic to yeast or yeast products.
Design:
- Initial physical examination, blood and tissue sampling, computed tomography (CT) scan, and skin test to determine eligibility for the procedure.
- Treatment with GI-6027 in seven 14-day cycles as follows:
- Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85.
- Vaccine given at four sites around the body: right and left chest area below the armpit, and right and left upper thigh in the pelvic region. (These areas drain into parts of your body that contain large numbers of lymph nodes. The lymph nodes contain immune cells that may be activated by the vaccine to target cancer cells.)
- Clinic visits for physical examinations to check vital signs, take additional blood and urine samples, and perform other tests needed for the study.
- After day 85 (about 3 months), patients will continue to receive vaccine monthly (or every 28 days) as long as the vaccine is not producing harmful effects or side effects and the cancer is either stable or reducing. Patients who do well on the vaccine may continue to receive it for as long as it is available.
Detailed description
Background:
Carcinoembryonic antigen (CEA) is overexpressed in multiple adenocarcinomas.
Previous clinical studies utilizing CEA-based vaccine therapy have demonstrated safety, T-cell immune responses against CEA, and preliminary evidence of clinical benefit.
Preclinical studies have shown that Saccharomyces-CEA (yeast-CEA) can induce a strong immune response to CEA as well as therapeutic antitumor responses in a CEA-transgenic host.
Previous and ongoing clinical studies utilizing whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express mutated Ras (GI-4000) or hepatitis C (GI-5005) proteins demonstrated this vaccine vehicle to be well tolerated, with no product-related serious adverse events in >200 treated subjects.
Objectives:
Primary
-To determine the safety and tolerability of escalating doses of a heat-killed yeast-based vaccine that targets tumors that express CEA.
Secondary
- To evaluate CD4 and CD8 immunologic response as measured by an increase in CEA-specific T cells measured by ELISPOT in HLA-A2, -A3 and -A24(+) patients, and proliferation in response to CEA protein.
- To evaluate evidence of clinical benefit, such as progression-free survival, RECIST criteria, reduction in serum markers, and/or reduction in circulating tumor cells.
Eligibility: (dose escalation phase)
Must have metastatic cancer that is CEA-positive (either a CEA serum level > 5 ng/mL or a tumor that stains positive for CEA in > 20% of a tumor block).
Must have completed or had disease progression on at least one prior line of disease-appropriate therapy, or not be a candidate for therapy of proven efficacy for their disease.
Must be ECOG Performance Status 0 2.
Should have no autoimmune diseases; no evidence of immune dysfunction; no serious intercurrent medical illness;
No untreated brain metastasis (or local treatment of brain metastases within the last 6 months)
Any hypersensitivity reaction to yeast-based products.
Eligibility: (extension phase: 10 additional patients at highest tested dose/MTD)
Same as for the dose escalation phase with the following exceptions:
- Patients must be HLA-A2, -A3, or -A24(+) for immunologic monitoring
- ECOG PS = 0 1
Design:
This is an open label, phase I trial with sequential cohorts of patients (3-6 patients per dose cohort) with dose escalation of heat-killed GI-6207 vaccine (see statistical analysis section).
GI 6207 vaccine will be administered subcutaneously at 4 sites biweekly for 7 visits (days 1, 15, 29, 43, 57, 71, 85), then monthly until patients meet off-study criteria.
All patients on a given dose level will have completed 1 month on-study before enrollment can begin on the next dose level or on the extension phase (see statistical analysis section).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed carcinoma by the NIH Laboratory of Pathology that has been shown to express CEA (either a CEA serum level > 5 microg/L or a tumor that stains positive for CEA in > 20% of a tumor block).
- Completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be a candidate for therapy of proven efficacy for their disease.
- 18 years of age or greater.
- Must have metastatic disease that is measurable or non-measurable but evaluable (e.g., pleural effusion or present on bone scan).
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (11 listed)
- Patients should have no evidence of immune dysfunction as listed below.
- Human immunodeficiency virus positivity due to the potential for decreased immune response to the vaccine.
- Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. Patients with endocrine autoimmune disease that is controlled by replacement therapy, including thyroid disease and adrenal disease; or those with vitiligo, may be enrolled.
- Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids to prevent IV contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed.
- History of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI-6207 [Recombinant Saccharomyces Cerevisia | Biological | – |
| (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)]) | Drug | – |
Primary outcome
To determine the safety and tolerability of escalating doses of a heated-killed yeast-based vaccine that targets tumors that express CEA.
1 secondary outcome
To evaluate CD4 and CD8 immunologic response. To evaluate humoral immune response to yeast antigen. To evaluate evidence of clinical benefit such as PFS, OR, & decreases in circulating tumor cells & tumor markers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 8386136Robbins PF, Eggensperger D, Qi CF, Schlom J. Definition of the expression of the human carcinoembryonic antigen and non-specific cross-reacting antigen in human breast and lung carcinomas. Int J Cancer. 1993 Apr 1;53(6):892-7. doi: 10.1002/ijc.2910530604.
- Background: PubMed 12208760Kass ES, Greiner JW, Kantor JA, Tsang KY, Guadagni F, Chen Z, Clark B, De Pascalis R, Schlom J, Van Waes C. Carcinoembryonic antigen as a target for specific antitumor immunotherapy of head and neck cancer. Cancer Res. 2002 Sep 1;62(17):5049-57.
- Background: PubMed 12586096Hodge JW, Tsang KY, Poole DJ, Schlom J. General keynote: vaccine strategies for the therapy of ovarian cancer. Gynecol Oncol. 2003 Jan;88(1 Pt 2):S97-104; discussion S110-3. doi: 10.1006/gyno.2002.6694. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi A Madan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GI-6207 [Recombinant Saccharomyces Cerevisia and (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)]) in people with Prostate Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site 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?
The sponsor lists 22 inclusion and 11 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safety and tolerability of escalating doses of a heated-killed yeast-based vaccine that targets tumors that express CEA.. 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 NCT00924092, which also lists 3 linked publications.
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 12 Dec 2019.