Pancreatic CancerPhase 2NCT00002773
Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 study testing allogeneic tumor cell vaccine, recombinant interferon alfa and sargramostim in people with Pancreatic Cancer, run by St. Vincent Medical Center - Los Angeles at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- allogeneic tumor cell vaccine, recombinant interferon alfa and sargramostim
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1996to Apr 2004
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy No brain metastases refractory to irradiation or surgery
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent significant pulmonary disease Other: No AIDS HIV negative No prior or concurrent autoimmune disease No other concurrent major medical illness Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Vincent Medical Center - Los Angeles
Los Angeles, California, 90057
About this study
Official title: A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE
RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors may help a person's immune system recover from the side effects of chemotherapy. Combining these treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer.
Read the detailed description
OBJECTIVES: I. Determine the feasibility, toxicity, and antitumor effects of active specific intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon alfa plus low-dose adjuvant systemic sargramostim (GM-CSF) and cyclophosphamide in patients with incurable pancreatic adenocarcinoma. II. Assess the immunologic and biologic correlates of this treatment regimen in these patients.
OUTLINE: Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours. Autologous cell lines, if established, may be used as an alternative. The cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV on day -3 and sargramostim (GM-CSF) subcutaneously on days 0-8. On day 0, patients receive viable tumor cells via dorsal pedal lymphatic cannulation. Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-4 months.
PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- allogeneic tumor cell vaccine, recombinant interferon alfa, sargramostim, cyclophosphamide
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, 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.
allogeneic tumor cell vaccineBiological
recombinant interferon alfaBiological
sargramostimBiological
cyclophosphamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2004 (estimated)
- Study startMay 1996
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- St. Vincent Medical Center - Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- Charles L. Wiseman, MD, FACP, Study chair, St. Vincent Medical Center - Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002773
- Sponsor's protocol ID
- SVMC-ONC-222P
- Other IDs
- CDR0000064749, NCI-V96-0886
- Status last verified
- Apr 2007
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE
- ClinicalTrials.gov ID
- NCT00002773
- Acronym / sponsor ID
- SVMC-ONC-222P
- Conditions
- Pancreatic Cancer
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- St. Vincent Medical Center - Los AngelesUniversity, hospital or other
- Study start
- May 1996
- Study completion
- Apr 2004 (actual)
- First posted
- 29 Apr 2004 (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.
RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors may help a person's immune system recover from the side effects of chemotherapy. Combining these treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer.
Detailed description
OBJECTIVES: I. Determine the feasibility, toxicity, and antitumor effects of active specific intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon alfa plus low-dose adjuvant systemic sargramostim (GM-CSF) and cyclophosphamide in patients with incurable pancreatic adenocarcinoma. II. Assess the immunologic and biologic correlates of this treatment regimen in these patients.
OUTLINE: Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours. Autologous cell lines, if established, may be used as an alternative. The cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV on day -3 and sargramostim (GM-CSF) subcutaneously on days 0-8. On day 0, patients receive viable tumor cells via dorsal pedal lymphatic cannulation. Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-4 months.
PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| allogeneic tumor cell vaccine | Biological | – |
| recombinant interferon alfa | Biological | – |
| sargramostim | Biological | – |
| cyclophosphamide | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Jul 2013.
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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.
Charles L. Wiseman, MD, FACP study chair
St. Vincent Medical Center - Los Angeles
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 allogeneic tumor cell vaccine, recombinant interferon alfa and sargramostim in people with Pancreatic Cancer, run by St. Vincent Medical Center - Los Angeles 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 10 Jul 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 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?
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.
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 10 Jul 2013.