Ovarian NeoplasmsPhase 1NCT01095848
A Phase I Safety Study of a Cancer Vaccine to Treat HLA-A2 Positive Advanced Stage Ovarian, Breast and Prostate Cancer
A Phase 1 study testing DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG in people with Ovarian Neoplasms and Breast Neoplasms, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 5 sites in United States.
Trial summary
To determine the safety and immunogenicity profile of two (2) different doses of the vaccine DPX-0907 to treat breast, ovarian and prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms
- What is being tested?
- DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2010to Nov 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage III or IV ovarian cancer who have completed a course of platinin-based cytotoxic therapy after debulking surgery with evidence of a complete or partial response by radiological imaging. Patients with metastatic ovarian cancer who have stable disease for greater than 3 months after completion of first-line therapy.
- Patients with stage IV breast cancer who have received at least 1 course of hormonal or cytotoxic therapy for metastatic cancer. Patients must be off cytotoxic therapy with stable disease or better for 3 months or greater duration. Patients may have stable disease and still be on hormonal therapy.
- Patients with prostate cancer who have failed at least 1 course of an accepted hormonal therapy. Specifically prostate cancer patients must have castrate testosterone levels (< 50 ng/dl) and 2 PSA values higher than the previously documented baseline at least 3 weeks apart or evidence of increases in measurable disease. These patients may have received previous courses of cytotoxic chemotherapy although chemotherapy naïve patients who are deemed not good candidates or who have refused cytotoxic therapy will be eligible. These patients may remain on anti-androgen therapy during the trial. Patients with evidence of progressive bone or other metastases are acceptable.
- At least 8 weeks since previous courses of an investigational biologic therapy (i.e. cancer vaccine) including active or passive immunotherapy.
- At least 30 days since localized surgery or radiotherapy.
- At least 30 days since initiation of a biphosphonate treatment.
- HLA A2 haplotype.
Who cannot join
- History of autoimmune disease, such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with a remote history (greater than five years) of thyroiditis are not excluded.
- Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection such as: urinary tract infection, HIV, or antigen positive viral hepatitis.
- Previously resected brain metastases unless a CT or MRI scan of the brain shows no metastasis within 1 month of receiving DPX-0907.
- Concurrent (within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer.
- Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions.
- Serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV) or hepatic disease.
Show all 13Show fewer
- Steroid therapy or other immunosuppressives, such as azathioprine or cyclosporin A, unless steroids are discontinued 6 weeks prior to study.
- Allergies to any component of the vaccine.
- Inability to gain venous access.
- Previous splenectomy.
- Previous lymphadenectomy in both inguinal regions.
- Pregnant or nursing mothers.
- Medical or psychological impediment or active drug or alcohol use that might preclude protocol compliance.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Rush University Medical Center
Chicago, Illinois, 60612-3244
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
Duke University Medical Center
Durham, North Carolina, 27710
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase I Study of Two Different Doses of the Subcutaneous Administration of an Immunotherapeutic Vaccine, DPX-0907 in Advanced Stage Patients With Ovarian, Breast or Prostate Cancer
To determine the safety and immunogenicity profile of two (2) different doses of the vaccine DPX-0907 to treat breast, ovarian and prostate cancer.
Read the detailed description
Epithelial ovarian cancer has a high mortality rate even among those who obtain complete remission after surgery and chemotherapy. In prostate cancer, hormonal therapies including androgen ablation may control the disease for variable lengths of time but progression will invariably occur. There is also a high rate of relapse in breast cancer patients who have four or more positive axillary lymph nodes and in cases of resected metastatic disease. Immune therapies such as therapeutic vaccination may prolong remissions in these cancers.
Many different therapeutic vaccines have been evaluated in these diseases in phase 1, 2 and even phase 3 trials. Much has been learned about the principals of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. Cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease. Most recently an overall survival benefit was documented in prostate cancer patients with an immunotherapy based vaccine.
ImmunoVaccine Technologies Inc. (IVT) is developing a therapeutic vaccine against various solid cancers based on a patented vaccine delivery and enhancement platform. The antigens included in DPX-0907 were identified using an innovative antigen discovery platform to identify proprietary signature antigens actually presented on the surface of tumor cells and therefore capable of stimulating a cellular immune response in the patient. One or more of the peptide antigens are expected to be expressed in the types of tumors included in this trial. The peptide antigens proposed for DPX-0907 have been previously included in a phase I study in a different vaccine formulation at Duke University. No vaccine-induced autoimmune events were reported. These encouraging results suggest that the autoimmune potential of these cancer-specific peptide antigens is limited. IVT's DepoVax™ (DPX) lipid-based formulation was designed to enhance the speed, strength and duration of the cellular immune response. This formulation in combination with tumor targeting antigens has produced favorable safety and cellular immune responses in preclinical studies. These parameters will be studied in this phase I trial.
- Conditions
- Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms
- Being tested
- DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG
- Keywords
- vaccine, cancer, ovarian, breast, prostate, tumor, Immunotherapy
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VGBiological
Patients will receive three deep subcutaneous injections of the vaccine three weeks apart in the upper thigh region. Patients will be followed for up to 7 months.
| Study group | Role | What they receive |
|---|---|---|
| 0.25ml dose DPX-0907 | Experimental | On each vaccination day the lyophilized antigen/adjuvant/liposome complex is re-suspended in the oil (Montanide 1SA51 VG) before injection. The vaccine is not an emulsion. Receives: Biological: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG |
| 1ml dose DPX-0907 | Experimental | On each vaccination day the lyophilized antigen/adjuvant/liposome complex is re-suspended in the oil (Montanide 1SA51 VG) before injection. The vaccine is not an emulsion. Receives: Biological: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests.
Measured: On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period
Secondary outcomes (2)
To determine the levels of CMI (cell mediated immunity) to the 7 cancer epitopes induced by vaccination with DPX-0907
Measured: On each vaccination day, 30 days after last vaccination
To establish a recommended dose based on safety and immune response for phase 2 studies.
Measured: On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Morse, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095848
- Sponsor's protocol ID
- ONC-DPX-0907-01
- Status last verified
- Dec 2015
- First submitted
- 26 Mar 2010
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berinstein NL, Karkada M, Morse MA, Nemunaitis JJ, Chatta G, Kaufman H, Odunsi K, Nigam R, Sammatur L, MacDonald LD, Weir GM, Stanford MM, Mansour M. First-in-man application of a novel therapeutic cancer vaccine formulation with the capacity to induce multi-functional T cell responses in ovarian, breast and prostate cancer patients. J Transl Med. 2012 Aug 3;10:156. doi: 10.1186/1479-5876-10-156.
PubMed 22862954
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Two Different Doses of the Subcutaneous Administration of an Immunotherapeutic Vaccine, DPX-0907 in Advanced Stage Patients With Ovarian, Breast or Prostate Cancer
- ClinicalTrials.gov ID
- NCT01095848
- Acronym / sponsor ID
- ONC-DPX-0907-01
- Conditions
- Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms
- Keywords
- vaccine, cancer, ovarian, breast, prostate, tumor, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Mar 2010 (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.
To determine the safety and immunogenicity profile of two (2) different doses of the vaccine DPX-0907 to treat breast, ovarian and prostate cancer.
Detailed description
Epithelial ovarian cancer has a high mortality rate even among those who obtain complete remission after surgery and chemotherapy. In prostate cancer, hormonal therapies including androgen ablation may control the disease for variable lengths of time but progression will invariably occur. There is also a high rate of relapse in breast cancer patients who have four or more positive axillary lymph nodes and in cases of resected metastatic disease. Immune therapies such as therapeutic vaccination may prolong remissions in these cancers.
Many different therapeutic vaccines have been evaluated in these diseases in phase 1, 2 and even phase 3 trials. Much has been learned about the principals of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. Cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease. Most recently an overall survival benefit was documented in prostate cancer patients with an immunotherapy based vaccine.
ImmunoVaccine Technologies Inc. (IVT) is developing a therapeutic vaccine against various solid cancers based on a patented vaccine delivery and enhancement platform. The antigens included in DPX-0907 were identified using an innovative antigen discovery platform to identify proprietary signature antigens actually presented on the surface of tumor cells and therefore capable of stimulating a cellular immune response in the patient. One or more of the peptide antigens are expected to be expressed in the types of tumors included in this trial. The peptide antigens proposed for DPX-0907 have been previously included in a phase I study in a different vaccine formulation at Duke University. No vaccine-induced autoimmune events were reported. These encouraging results suggest that the autoimmune potential of these cancer-specific peptide antigens is limited. IVT's DepoVax™ (DPX) lipid-based formulation was designed to enhance the speed, strength and duration of the cellular immune response. This formulation in combination with tumor targeting antigens has produced favorable safety and cellular immune responses in preclinical studies. These parameters will be studied in this phase I trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25ml dose DPX-0907 | Experimental | Biological: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VGOn each vaccination day the lyophilized antigen/adjuvant/liposome complex is re-suspended in the oil (Montanide 1SA51 VG) before injection. The vaccine is not an emulsion. |
| 1ml dose DPX-0907 | Experimental | Biological: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VGOn each vaccination day the lyophilized antigen/adjuvant/liposome complex is re-suspended in the oil (Montanide 1SA51 VG) before injection. The vaccine is not an emulsion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with stage III or IV ovarian cancer who have completed a course of platinin-based cytotoxic therapy after debulking surgery with evidence of a complete or partial response by radiological imaging. Patients with metastatic ovarian cancer who have stable disease for greater than 3 months after completion of first-line therapy.
- Patients with stage IV breast cancer who have received at least 1 course of hormonal or cytotoxic therapy for metastatic cancer. Patients must be off cytotoxic therapy with stable disease or better for 3 months or greater duration. Patients may have stable disease and still be on hormonal therapy.
- Patients with prostate cancer who have failed at least 1 course of an accepted hormonal therapy. Specifically prostate cancer patients must have castrate testosterone levels (< 50 ng/dl) and 2 PSA values higher than the previously documented baseline at least 3 weeks apart or evidence of increases in measurable disease. These patients may have received previous courses of cytotoxic chemotherapy although chemotherapy naïve patients who are deemed not good candidates or who have refused cytotoxic therapy will be eligible. These patients may remain on anti-androgen therapy during the trial. Patients with evidence of progressive bone or other metastases are acceptable.
- At least 8 weeks since previous courses of an investigational biologic therapy (i.e. cancer vaccine) including active or passive immunotherapy.
- At least 30 days since localized surgery or radiotherapy.
Key exclusion criteria (13 listed)
- History of autoimmune disease, such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with a remote history (greater than five years) of thyroiditis are not excluded.
- Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection such as: urinary tract infection, HIV, or antigen positive viral hepatitis.
- Previously resected brain metastases unless a CT or MRI scan of the brain shows no metastasis within 1 month of receiving DPX-0907.
- Concurrent (within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer.
- Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions.
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 |
|---|---|---|
| DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VGPatients will receive three deep subcutaneous injections of the vaccine three weeks apart in the upper thigh region. Patients will be followed for up to 7 months. | Biological | 0.25ml dose DPX-0907, 1ml dose DPX-0907 |
Primary outcome
To determine the safety profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests.
Time frame: On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period
2 secondary outcomes
To determine the levels of CMI (cell mediated immunity) to the 7 cancer epitopes induced by vaccination with DPX-0907
Time frame: On each vaccination day, 30 days after last vaccination
To establish a recommended dose based on safety and immune response for phase 2 studies.
Time frame: On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period
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 15 Dec 2015.
- Results publication: PubMed 22862954Berinstein NL, Karkada M, Morse MA, Nemunaitis JJ, Chatta G, Kaufman H, Odunsi K, Nigam R, Sammatur L, MacDonald LD, Weir GM, Stanford MM, Mansour M. First-in-man application of a novel therapeutic cancer vaccine formulation with the capacity to induce multi-functional T cell responses in ovarian, breast and prostate cancer patients. J Transl Med. 2012 Aug 3;10:156. doi: 10.1186/1479-5876-10-156.
Related trials for Ovarian Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Michael Morse, MD study chair
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG in people with Ovarian Neoplasms and Breast Neoplasms, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 5 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?
The sponsor lists 7 inclusion and 13 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests. (time frame: On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period). 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 NCT01095848, which also lists 1 linked publication.
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 15 Dec 2015.