Ovarian CancerPhase 1NCT00683241
A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine for Recurrent Ovarian or Primary Peritoneal Cancer
A Phase 1 study testing DCVac-L in people with Ovarian Cancer and Peritoneal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion in order to make the first part of the vaccine or lysate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer
- What is being tested?
- DCVac-L
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent stage II to IV ovarian carcinoma or primary peritoneal carcinoma.
- Subjects with prior secondary cytoreductive surgery or aspiration of malignant effusion yielding tumor for lysate preparation.
- Subjects must have sufficient lysate for DCVax-L preparation (> 10 mg of pure protein lysate from tumor, ascites or malignant pleural effusion cell preparation).
- largest tumor nodule ≤ 2.5 cm
- Patients who have achieved complete response following surgery and chemotherapy are still eligible for vaccine.
- may be platinum-sensitive or platinum-resistant
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- may have received chemotherapy or other therapy after harvest of tumor
- must have recovered from toxicities of prior chemotherapy or other therapy.
- completed all parenteral investigational therapy 14 days and have completed all oral investigational therapy 7 days prior to enrollment
- must have completed all hormonal therapy 7 days prior to enrollment.
- must have recovered from toxicities of radiation therapy (to grade 2 or less).
- at least 4 weeks postoperative recovery
- coagulation studies w/i normal limits
- ECOG > 2
- Life expectancy of > 4 months.
- must understand and sign the study specific informed consent.
Who cannot join
- not enough lysate for vaccine preparation
- known brain metastases
- any of the following positive tests at the screening visit: (HTLV-1/2 ; Hepatitis B, HIV, Hepatitis C, Anti-Yo(cdr2) antibody present in serum
- on corticosteroids
- prior IV Cytoxan at maximally tolerated dose
- serum creatinine > 2.2 mg/dl or BUN > 40 mg/dl
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- proteinuria > 3.5gm over 24 hrs
- serum total bilirubin > 2.0 and/or serum transaminases > 3X the upper limits of normal
- Platelets < 100,000/ mm3 ; WBC < 3,000/mm3 ; Absolute Neutrophil Count (ANC) < 1,500/mm3 ; Absolute lymphocyte count < 1000/ mm3 ; Hematocrit < 30%
- acute infection that requires specific therapy
- serious, non-healing wound, ulcer, or bone fracture
- active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
- history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
- clinically significant cardiovascular disease; this includes: (Uncontrolled hypertension ; Myocardial infarction or unstable angina within 6 months prior to registration ; New York Heart Association (NYHA) Grade II or greater congestive heart failure ; Serious cardiac arrhythmia requiring medication ; Grade II or greater peripheral vascular disease.
- clinically significant peripheral artery disease, e.g., those with claudication, within 6 months.
- clinical symptoms or signs of partial or complete gastrointestinal obstruction or who require parenteral hydration and/or nutrition.
- any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study). Subjects with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- organ allografts.
- known autoimmune/collagen vascular disorder.
- on any medications that might affect immune function. Additionally, H2 antagonists are excluded as are all antihistamines five days before and five days after each injection of study drug. NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are exceptions.
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Leaded With Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer
This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion in order to make the first part of the vaccine or lysate. If enough of the lystate had been collected to make the first part of the vaccine, then subjects may enroll in the study as long as they meet the rest of the entry criteria.
After is determined that a subject is eligible to enroll into the study, you will have to donate some blood in order to make the second part of the vaccine. After this, the blood and vaccine are mixed together to make the vaccine called DCVax-L. You will be given two dose of a drug called Avastin every other week (Avastin will be given through your vein) and a oral chemotherapy called Cytoxan. One week after your last dose of oral Cytoxan, you will receive 3 vaccines given every other week for the next month. After the first two doses of vaccine, you will also receive more Avastin. During the study you will be seeing your study team to have physical exams, blood drawn in order to monitor your health and have blood drawn for research. The study team will contact you for the next 5 years in order to determine how you are doing.
Read the detailed description
Subjects with recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer, for whom autologous tumor or malignant effusion has been harvested and is available for lysate preparation, are eligible, provided all other eligibility criteria are fulfilled. Harvested tumor or malignant effusion will be shipped to Cognate BioServices (Sunnyvale, CA) for preparation of lysate. If sufficient amount of lysate for vaccine can be generated, subjects will be enrolled to the study.
Subjects will undergo apheresis on day -35 to -29 to harvest peripheral blood mononuclear cells (PBMC). The apheresis product will be shipped to Cognate BioServices, where DC will be prepared and pulsed with autologous lysate according to proprietary technology. Following apheresis, subjects will receive two cycles of biological antiangiogenesis/immunomodulatory therapy comprising intravenous bevacizumab at 10 mg/kg on day -28 and -14, which may be followed by 7 days of oral metronomic cyclophosphamide at 50 mg daily (days -28 to -21, and -14 to -7, respectively). Subjects will receive three doses of intradermal vaccination with ~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28. Subjects will also receive intravenous bevacizumab at 10 mg/kg concurrently with intradermal DCVax-L on day 0 and 14, which may be followed by oral cyclophosphamide at 50 mg for 7 days (days 0 to 7, and 14 to 21, respectively). The last DCVax-L (day 28) may be followed by oral cyclophosphamide at 50 mg daily x 7 days (days 28 to 35), but no bevacizumab will be given on day 28. Prevnar, an FDA approved seven-valent vaccine against Pneumococcus pneumoniae, will be given intramuscularly on day 0 as positive control of immune responsiveness. Two weeks following third vaccine dose (day 42), patients will undergo immune assessment.
Subjects will be contacted every 6 months for 5 years and then annually for survival. Subject will have the option of enrolling in other combinatorial immunotherapy trials when these are available, if they satisfy enrollment criteria. Subjects will have the option of continuing vaccination every two months till exhaustion of DCVax-L or disease progression, whichever occurs first.
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Being tested
- DCVac-L
- Keywords
- Vaccine, Ovarian, Peritoneal
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVac-LBiological
Subjects will receive three doses of intradermal vaccination with ~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects with stage II to IV recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer, from whom solid tumor, ascites or pleural effusion will be harvested and available and sufficient for lysate preparation; and whose largest tumor nodule is ≤ 2.5 cm. Subjects may have undergone chemotherapy or other therapy following tumor harvesting and prior to enrollment (apheresis). Receives: Biological: DCVac-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and safety of administering DCVax-L intradermally combined with intravenous bevacizumab and oral metronomic cyclophosphamide in patients with recurrent ovarian or primary peritoneal cancer.
Measured: 2 years
Secondary outcomes (1)
To assess the immunogenicity of DCVax-L administered intradermally in patients with recurrent ovarian or recurrent primary peritoneal cancer, combined with intravenous bevacizumab and oral metronomic cyclophosphamide.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Northwest Biotherapeutics, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- George Coukos, M.D., Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683241
- Sponsor's protocol ID
- UPCC 11807
- Status last verified
- Feb 2013
- First submitted
- 19 May 2008
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Leaded With Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00683241
- Acronym / sponsor ID
- UPCC 11807
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Keywords
- Vaccine, Ovarian, Peritoneal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Northwest Biotherapeutics, University of California, San Francisco
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 May 2008 (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.
This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion in order to make the first part of the vaccine or lysate. If enough of the lystate had been collected to make the first part of the vaccine, then subjects may enroll in the study as long as they meet the rest of the entry criteria.
After is determined that a subject is eligible to enroll into the study, you will have to donate some blood in order to make the second part of the vaccine. After this, the blood and vaccine are mixed together to make the vaccine called DCVax-L. You will be given two dose of a drug called Avastin every other week (Avastin will be given through your vein) and a oral chemotherapy called Cytoxan. One week after your last dose of oral Cytoxan, you will receive 3 vaccines given every other week for the next month. After the first two doses of vaccine, you will also receive more Avastin. During the study you will be seeing your study team to have physical exams, blood drawn in order to monitor your health and have blood drawn for research. The study team will contact you for the next 5 years in order to determine how you are doing.
Detailed description
Subjects with recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer, for whom autologous tumor or malignant effusion has been harvested and is available for lysate preparation, are eligible, provided all other eligibility criteria are fulfilled. Harvested tumor or malignant effusion will be shipped to Cognate BioServices (Sunnyvale, CA) for preparation of lysate. If sufficient amount of lysate for vaccine can be generated, subjects will be enrolled to the study.
Subjects will undergo apheresis on day -35 to -29 to harvest peripheral blood mononuclear cells (PBMC). The apheresis product will be shipped to Cognate BioServices, where DC will be prepared and pulsed with autologous lysate according to proprietary technology. Following apheresis, subjects will receive two cycles of biological antiangiogenesis/immunomodulatory therapy comprising intravenous bevacizumab at 10 mg/kg on day -28 and -14, which may be followed by 7 days of oral metronomic cyclophosphamide at 50 mg daily (days -28 to -21, and -14 to -7, respectively). Subjects will receive three doses of intradermal vaccination with ~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28. Subjects will also receive intravenous bevacizumab at 10 mg/kg concurrently with intradermal DCVax-L on day 0 and 14, which may be followed by oral cyclophosphamide at 50 mg for 7 days (days 0 to 7, and 14 to 21, respectively). The last DCVax-L (day 28) may be followed by oral cyclophosphamide at 50 mg daily x 7 days (days 28 to 35), but no bevacizumab will be given on day 28. Prevnar, an FDA approved seven-valent vaccine against Pneumococcus pneumoniae, will be given intramuscularly on day 0 as positive control of immune responsiveness. Two weeks following third vaccine dose (day 42), patients will undergo immune assessment.
Subjects will be contacted every 6 months for 5 years and then annually for survival. Subject will have the option of enrolling in other combinatorial immunotherapy trials when these are available, if they satisfy enrollment criteria. Subjects will have the option of continuing vaccination every two months till exhaustion of DCVax-L or disease progression, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: DCVac-LSubjects with stage II to IV recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer, from whom solid tumor, ascites or pleural effusion will be harvested and available and sufficient for lysate preparation; and whose largest tumor nodule is ≤ 2.5 cm. Subjects may have undergone chemotherapy or other therapy following tumor harvesting and prior to enrollment (apheresis). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Recurrent stage II to IV ovarian carcinoma or primary peritoneal carcinoma.
- Subjects with prior secondary cytoreductive surgery or aspiration of malignant effusion yielding tumor for lysate preparation.
- Subjects must have sufficient lysate for DCVax-L preparation (> 10 mg of pure protein lysate from tumor, ascites or malignant pleural effusion cell preparation).
- largest tumor nodule ≤ 2.5 cm
- Patients who have achieved complete response following surgery and chemotherapy are still eligible for vaccine.
Key exclusion criteria (21 listed)
- not enough lysate for vaccine preparation
- known brain metastases
- any of the following positive tests at the screening visit: (HTLV-1/2 ; Hepatitis B, HIV, Hepatitis C, Anti-Yo(cdr2) antibody present in serum
- on corticosteroids
- prior IV Cytoxan at maximally tolerated dose
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 |
|---|---|---|
| DCVac-LSubjects will receive three doses of intradermal vaccination with ~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28 | Biological | 1 |
Primary outcome
To determine the feasibility and safety of administering DCVax-L intradermally combined with intravenous bevacizumab and oral metronomic cyclophosphamide in patients with recurrent ovarian or primary peritoneal cancer.
Time frame: 2 years
1 secondary outcome
To assess the immunogenicity of DCVax-L administered intradermally in patients with recurrent ovarian or recurrent primary peritoneal cancer, combined with intravenous bevacizumab and oral metronomic cyclophosphamide.
Time frame: 2 years
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 26 Feb 2013.
- Gynecologic Oncology @ University of PennsylvaniaLink provided by the sponsor.
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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.
George Coukos, M.D., Ph.D. principal investigator
University of Pennsylvania
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 DCVac-L in people with Ovarian Cancer and Peritoneal Cancer, run by Abramson Cancer Center at Penn Medicine 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 16 inclusion and 21 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 26 Feb 2013. 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 feasibility and safety of administering DCVax-L intradermally combined with intravenous bevacizumab and oral metronomic cyclophosphamide in patients with recurrent ovarian or primary peritoneal cancer. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2013.