ChemotherapyEarly Phase 1NCT01132014
Autologous OC-DC Vaccine in Ovarian Cancer
A Early Phase 1 study testing OCDC in people with Chemotherapy and Tumor, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy, Tumor, Ovarian Cancer
- What is being tested?
- OCDC
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 30 May 2018
- Phase
- Early 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
None listed.
Who cannot join
- Subject for whom tumor lysate does not meet release criteria
- Subject has a positive serum Yo antibody
- Subject whose groins are not accessible.
- Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included.
- Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included.
- Subject has positive test result at the screening visit for one or more of the following:
Show all 32Show fewer
- HTLV-1/2
- Anti-HIV 1 Antibody (α-HIV-1)
- Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.
- Subject has renal insufficiency as defined by a serum creatinine greater than 2.2 mg/dl or BUN greater than 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
- Subject has proteinuria greater than 3.5 gm over 24 hrs are not eligible for the study (cohort 2 only)
- Subject with liver failure as defined by a serum total bilirubin greater than 2.0 and/or serum transaminases greater than 3X the upper limits of normal.
- Subject has hematopoietic failure at baseline as defined by one of the following:
- Platelets less than 100,000/ mm3
- WBC less than 2,500/mm3
- Absolute Neutrophil Count (ANC) less than 1,000/mm3
- Absolute lymphocyte count less than 200/ mm3
- Hematocrit less than or equal to 30 percent
- Subject has any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
- Subject has a serious, non-healing wound, ulcer, or bone fracture.
- Subject has a clinically significant cardiovascular disease including:
- Uncontrolled hypertension;
- Myocardial infarction or unstable angina within 6 months prior to enrollment
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Subject has a grade II or greater peripheral vascular disease.
- Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months.
- Subject has any underlying conditions, which would contraindicate therapy with study treatment (or allergies to reagents used in this study).
- Subject has organ allografts.
- Subject is receiving medication(s) that might affect immune function. Use of H2 antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine. However, NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are permitted.
- Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or who require parenteral hydration and/or nutrition (For cohort 2, 3, 4 and 5).
- Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.
- Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Ovarian Cancer Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.
- Conditions
- Chemotherapy, Tumor, Ovarian Cancer
- Being tested
- OCDC
- Keywords
- Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer,, from whom solid tumor or ascites have been harvested and are available and, sufficient for tumorlysate preparation;and whose largest tumor nodule is 4.5, cm. Subjects may have undergone chemotherapy or other therapy following, tumor harvesting and prior to enrollment.
- Medical subject headings
- Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCDCBiological
OCDC,an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.
Measured: 30 days of last vaccination
Secondary outcomes (3)
Clinical Response
Clinical Response will be determined by RECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
Dose limiting toxicity
Dose-limiting toxicity is defined as: any Grade 3 or higher allergic, autoimmune or injection site reaction or any Grade 4 hematologic or non-hematologic toxicity (except fever).
Immune Response Immune Response
Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLAA2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a 3 fold increase relative to pre-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completion30 May 2018
- Study completion30 May 2018
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 ChemotherapyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132014
- Sponsor's protocol ID
- UPCC 19809
- Status last verified
- Apr 2018
- First submitted
- 26 May 2010
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Chiang CL, Maier DA, Kandalaft LE, Brennan AL, Lanitis E, Ye Q, Levine BL, Czerniecki BJ, Powell DJ Jr, Coukos G. Optimizing parameters for clinical-scale production of high IL-12 secreting dendritic cells pulsed with oxidized whole tumor cell lysate. J Transl Med. 2011 Nov 14;9:198. doi: 10.1186/1479-5876-9-198.
PubMed 22082029
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT01132014
- Acronym / sponsor ID
- UPCC 19809
- Conditions
- Chemotherapy, Tumor, Ovarian Cancer
- Keywords
- Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer,, from whom solid tumor or ascites have been harvested and are available and, sufficient for tumorlysate preparation;and whose largest tumor nodule is 4.5, cm. Subjects may have undergone chemotherapy or other therapy following, tumor harvesting and prior to enrollment.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 27 May 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.
This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- Subject for whom tumor lysate does not meet release criteria
- Subject has a positive serum Yo antibody
- Subject whose groins are not accessible.
- Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included.
- Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included.
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 |
|---|---|---|
| OCDCOCDC,an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab. | Biological | – |
Primary outcome
Safety
Time frame: 30 days of last vaccination
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.
3 secondary outcomes
Clinical Response
Dose limiting toxicity
Immune Response Immune Response
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 11 Jun 2018.
- Derived from this study: PubMed 22082029Chiang CL, Maier DA, Kandalaft LE, Brennan AL, Lanitis E, Ye Q, Levine BL, Czerniecki BJ, Powell DJ Jr, Coukos G. Optimizing parameters for clinical-scale production of high IL-12 secreting dendritic cells pulsed with oxidized whole tumor cell lysate. J Transl Med. 2011 Nov 14;9:198. doi: 10.1186/1479-5876-9-198.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OCDC in people with Chemotherapy and Tumor, 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 0 inclusion and 32 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 11 Jun 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Safety (time frame: 30 days of last vaccination). 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 NCT01132014, 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 11 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.