Pancreatic CancerPhase 2NCT00305760
Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
A Phase 2 study testing Cetuximab, Pancreatic tumor vaccine and Cyclophosphamide in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cetuximab, Pancreatic tumor vaccine and Cyclophosphamide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal adenocarcinoma of the pancreas
- Mixed adenocarcinoma tumors eligible provided the predominant invasive component of the tumor is adenocarcinoma
- The following histologic diagnoses are not eligible:
- Adenosquamous
- Squamous cell
- Colloid
- Islet cell
- Serous or mucinous cystadenoma or cystadenocarcinoma
- Carcinoid
- Small or large cell carcinoma
- Intraductal oncocytic papillary neoplasms
- Osteoclast-like giant cell tumors
- Acinar cell carcinoma
- Pancreatoblastoma
- Solid pseudopapillary tumors
- Undifferentiated small cell carcinoma
- Nonepithelial tumors (sarcoma, gastrointestinal stromal tumor, lymphoma)
- Adenocarcinomas of the ampulla, distal bile duct, or duodenum
- Metastatic or locally advanced disease that is refractory to standard therapy OR for which patient refused standard therapy
- Measurable disease defined as ≥ 1 lesion unidimensionally measured as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- No nonmeasurable disease only including, but not limited to, the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No known active or untreated brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,500/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 90,000/mm^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2 mg/dL
- ALT and AST ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- No active infection
- No uncontrolled medical condition that would potentially increase the risk of toxicities or complications of study therapy
- No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- No active peptic ulcer disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
- No other malignancy within the past 5 years except for nonmelanomatous skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- HIV negative
- No active autoimmune disease or prior autoimmune disease requiring medical treatment with systemic immunosuppressants including any of the following:
- Inflammatory bowel disease
- Systemic vasculitis
- Scleroderma
- Psoriasis
- Multiple sclerosis
- Hemolytic anemia or immune thrombocytopenia
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Sjögren's syndrome
- Sarcoidosis
- Asthma or chronic obstructive pulmonary disease that does not require systemic corticosteroids or routine use of inhaled steroids allowed
- No known or suspected hypersensitivity to sargramostim (GM-CSF), cyclophosphamide, pentastarch, corn, or DMSO
- No prior severe infusion reaction (> grade 3) to a monoclonal antibody
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 1 month since prior adjuvant chemotherapy
- More than 4 weeks since prior surgery except for minor procedures (e.g., dental work, skin biopsy) and biliary stent placement
- No prior surgical procedures affecting absorption
- More than 4 weeks since prior radiotherapy
- More than 1 month since prior participation in an investigational new drug study
- No unresolved chronic toxicity (except alopecia) from prior anticancer therapy
- More than 28 days since prior systemic steroids
- No concurrent systemic steroids or immunosuppressive drugs
- Topical, inhaled, and intra-articular steroids allowed
- No other concurrent anticancer vaccine therapy
- No other concurrent chemotherapy, immunotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Erbitux (Cetuximab) for the Treatment of Advanced Pancreatic Adenocarcinoma
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of pancreatic tumor vaccine, cyclophosphamide, and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas.
Secondary
- Determine the overall, progression-free, and event-free survival of patients treated with this regimen.
- Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate stem cell antigen [PSCA], mutated k-ras-specific T-cell responses) with clinical response in patients treated with this regimen.
- Correlate downstream targets of epidermal growth factor receptor (EGFR) signaling (e.g., intratumor expression of Akt, Stat 3 and 5, mesothelin, mutated k-ras, and PSCA) with inhibition by cetuximab in patients treated with this regimen.
- Correlate inhibition of EGFR signaling (e.g., Stat 3 and 5) with improved specific mesothelin, PSCA, and mutated k-ras-specific T-cell responses in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor vaccine intradermally on day 1, and cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies.
At the completion of study treatment, patients are followed at 3 weeks and then every 4 weeks for 16 weeks.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- Cetuximab, Pancreatic tumor vaccine, Cyclophosphamide
- Keywords
- stage III pancreatic cancer, recurrent pancreatic cancer, duct cell adenocarcinoma of the pancreas, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.
Pancreatic tumor vaccineBiological
Also called PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine, GVAX
Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.
CyclophosphamideDrug
Also called Cytoxan
Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab | Experimental | Not described Receives: Drug: Cetuximab; Biological: Pancreatic tumor vaccine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startDec 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel A. Laheru, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305760
- Sponsor's protocol ID
- J0501
- Other IDs
- P30CA006973, BMS-CA225247
- Status last verified
- Feb 2020
- First submitted
- 21 Mar 2006
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Erbitux (Cetuximab) for the Treatment of Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00305760
- Acronym / sponsor ID
- J0501
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, recurrent pancreatic cancer, duct cell adenocarcinoma of the pancreas, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Posted 15 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of pancreatic tumor vaccine, cyclophosphamide, and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas.
Secondary
- Determine the overall, progression-free, and event-free survival of patients treated with this regimen.
- Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate stem cell antigen [PSCA], mutated k-ras-specific T-cell responses) with clinical response in patients treated with this regimen.
- Correlate downstream targets of epidermal growth factor receptor (EGFR) signaling (e.g., intratumor expression of Akt, Stat 3 and 5, mesothelin, mutated k-ras, and PSCA) with inhibition by cetuximab in patients treated with this regimen.
- Correlate inhibition of EGFR signaling (e.g., Stat 3 and 5) with improved specific mesothelin, PSCA, and mutated k-ras-specific T-cell responses in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor vaccine intradermally on day 1, and cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies.
At the completion of study treatment, patients are followed at 3 weeks and then every 4 weeks for 16 weeks.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab | Experimental | Drug: Cetuximab, Biological: Pancreatic tumor vaccine, Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CetuximabAlso: ErbituxCetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each. | Drug | Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab |
| Pancreatic tumor vaccineAlso: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine, GVAXVaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles. | Biological | Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab |
| CyclophosphamideAlso: CytoxanCyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles. | Drug | Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab |
Primary outcome
Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel A. Laheru, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Pancreatic tumor vaccine and Cyclophosphamide in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
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 19 Feb 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population (time frame: 7 months). 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 19 Feb 2020.