Pancreatic NeoplasmsPhase 1NCT00732082
Lag-3 and Gemcitabine for Treatment of Advanced Pancreas Cancer
A Phase 1 study testing Gemcitabine and LAG-3 in people with Pancreatic Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overall purpose of this research is to evaluate the safety and toxicity of an investigational medication, IMP321, in patients being treated with gemcitabine. IMP321 is a synthetic protein (made in the laboratory to simulate a protein that your body makes on its own) and was designed to stimulate the immune system… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Gemcitabine and LAG-3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2012
- 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
- Patient must have a newly diagnosed, histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma (primary tumor or metastasis). The histological slides or blocks must be available for review.
- Patient must have advanced disease (characterized by metastasis or locally advanced disease), or unable to undergo surgical treatment due to extent of disease or pre-existing health conditions precluding surgical treatment.
- Measurable or evaluable disease: RECIST Criteria will be used to assess and survey extent of disease
- Patients must be ≥ 18 years old.
- Performance Status: Karnofsky Performance Status (KPS) ≥ 70
- Life Expectancy > 12 weeks.
Show all 17Show fewer
- No previous history of chemotherapy for pancreas cancer in the metastatic setting prior to the start of protocol treatment.
- Patients must have recovered from uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- Patients must have adequate bone marrow function defined as an absolute neutrophil count >1,500/mm3, platelet count >100,000/mm3 and hemoglobin >10 g/dl.
- Patients must have adequate renal function defined as serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 60 ml/min/1.73m2 for patients with creatinine levels above 2.0 mg/dl.
- Patients must have adequate hepatic function with total bilirubin ≤ 1.5 times the institutional normal value and AST ≤ 2 times the institutional normal value.
- Patient must have no prior or current active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis or other rheumatologic disease. Asthma and chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.
- The patient with previous history of malignancy is eligible for this study only if the patient meets the following criteria for cancer survivor:
- (i) patient has undergone potentially curative therapy for all prior malignancies;
- (ii) patient has been considered disease free for at least 5 years.
- For all sexually active patients, the use of adequate barrier contraception (hormonal or barrier method of birth control) will be required during therapy, prior to study entry and for the duration of study participation. Patients must agree to refrain from becoming pregnant 2 years after beginning treatment with IMP321. Non-pregnant status will be determined in all women of childbearing potential.
- After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
Who cannot join
- Patient is currently receiving other investigational agents.
- Pregnant and nursing women patients are not eligible.
- Patients known to be HIV (patient self-report) positive are ineligible because of the potential inability to modulate immune responses.
- Patients with a QTc of >460 msec.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Soluble LAG-3 (IMP321) and Gemcitabine in Patients With Advanced Pancreas Cancer
The overall purpose of this research is to evaluate the safety and toxicity of an investigational medication, IMP321, in patients being treated with gemcitabine. IMP321 is a synthetic protein (made in the laboratory to simulate a protein that your body makes on its own) and was designed to stimulate the immune system with the overall objective of improving the body's capacity to react to your pancreas cancer.
Read the detailed description
This is a phase I, single center, open label, non-randomized, dose-escalation phase I study performed in the ambulatory setting in patients receiving first line chemotherapy for unresectable pancreas cancer with gemcitabine weekly and the investigational agent IMP321. IMP321 will be given at D2 and D16 of a 4-week cycle, for a period of 6 months. The hypothesis of this study is that IMP321 is safe for human administration. Additionally we hypothesize that IMP321 elicits an immunomodulatory effect that is therapeutic in the treatment of pancreas cancer.
Primary Objectives
- To evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in patients being treated with gemcitabine for advanced pancreas cancer.
- To determine any dose limiting toxicities of IMP321 in patients being treated with gemcitabine for advanced pancreas cancer.
Secondary Objectives
- To describe the pharmacokinetics of the last IMP321 subcutaneous injection compared to the first one, in a limited number of patients.
- To determine the pharmacodynamics of IMP321 therapy by:
- Quantify peripheral blood Treg (CD4+CD25+FoxP3+ T cells) in pancreatic cancer patients before and during treatment with IMP321 by flow cytometry.
- Evaluate the B- and T-cell responses to the pancreatic cancer-expressed antigen, mesothelin, by testing for antibodies and T-cell response by ELISpot.
- To evaluate the clinical response and time to disease progression with computed tomography examinations at two month intervals (current standard of care in gemcitabine-treated patients).
- Conditions
- Pancreatic Neoplasms
- Being tested
- Gemcitabine, LAG-3
- Keywords
- LAG-3 and gemcitabine treatment for advanced pancreas 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.
GemcitabineDrug
Also called Gemzar
LAG-3Biological
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 0 | Active comparator | Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle. Receives: Drug: Gemcitabine |
| Dose Level 1 | Experimental | Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle.
IMP321 3 mg SQ anterior surface of either the right or left thigh on Day 2.
The subsequent doses will be given by subcutaneous injection on the contralateral thigh.
Each single injection will be separated by a 13-day administration free period. Receives: Drug: Gemcitabine; Biological: LAG-3 |
| Dose Level 2 | Experimental | Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle.
IMP321 6.5 mg SQ anterior surface of either the right or left thigh on Day 2.
The subsequent doses will be given by subcutaneous injection on the contralateral thigh.
Each single injection will be separated by a 13-day administration free perio Receives: Drug: Gemcitabine; Biological: LAG-3 |
| Dose Level 3 | Experimental | Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle.
IMP321 13 mg SQ anterior surface of either the right or left thigh on Day 2.
The subsequent doses will be given by subcutaneous injection on the contralateral thigh.
Each single injection will be separated by a 13-day administration free perio Receives: Drug: Gemcitabine; Biological: LAG-3 |
| Dose Level 4 | Experimental | Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle.
IMP321 26 mg SQ anterior surface of either the right or left thigh on Day 2.
The subsequent doses will be given by subcutaneous injection on the contralateral thigh.
Each single injection will be separated by a 13-day administration free perio Receives: Drug: Gemcitabine; Biological: LAG-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in patients being treated with gemcitabine for advanced pancreas cancer.
Measured: 6 months
To determine the dose limiting toxicities of IMP321 in patients being treated with gemcitabine for advanced pancreas cancer.
Measured: 6 months
Secondary outcomes (3)
To describe the pharmacokinetics of the last IMP321 subcutaneous injection compared to the first one, in a limited number of patients.
Performed only in patients enrolled in dose level 3 and 4.
Measured: Pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours, and 96 hours after IMP321 administration
To determine the pharmacodynamics of IMP321 therapy
- Quantify peripheral blood Treg (CD4+ CD25+ Fox P3+ Tcells) in pancreatic cancer patients before and during treatment with IMP321 by flow cytometry.
- Evaluate the B- and T-cell responses to the pancreatic cancer-expressed antigen, mesothelin, by testing for antibodies and T-cell response by ELISpot
Measured: 6 months
To evaluate the clinical response and time to disease progression with computed tomography examinations at two month intervals (current standard of care in gemcitabine-treated patients).
Measured: survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionSep 2012
Why it stopped: Company manufacturing study drug was unable to continue production.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William G. Hawkins, M.D., Principal investigator, Washington Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732082
- Sponsor's protocol ID
- 07-0265
- Status last verified
- Jun 2013
- First submitted
- 6 Aug 2008
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Storniolo AM, Allerheiligen SR, Pearce HL. Preclinical, pharmacologic, and phase I studies of gemcitabine. Semin Oncol. 1997 Apr;24(2 Suppl 7):S7-2-S7-7.
PubMed 9194473Green MR. Gemcitabine safety overview. Semin Oncol. 1996 Oct;23(5 Suppl 10):32-5.
PubMed 8893879Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
PubMed 9196156Linehan DC, Goedegebuure PS. CD25+ CD4+ regulatory T-cells in cancer. Immunol Res. 2005;32(1-3):155-68. doi: 10.1385/IR:32:1-3:155.
PubMed 16106066Liyanage UK, Moore TT, Joo HG, Tanaka Y, Herrmann V, Doherty G, Drebin JA, Strasberg SM, Eberlein TJ, Goedegebuure PS, Linehan DC. Prevalence of regulatory T cells is increased in peripheral blood and tumor microenvironment of patients with pancreas or breast adenocarcinoma. J Immunol. 2002 Sep 1;169(5):2756-61. doi: 10.4049/jimmunol.169.5.2756.
PubMed 12193750Triebel F. LAG-3: a regulator of T-cell and DC responses and its use in therapeutic vaccination. Trends Immunol. 2003 Dec;24(12):619-22. doi: 10.1016/j.it.2003.10.001.
PubMed 14644131Buisson S, Triebel F. MHC class II engagement by its ligand LAG-3 (CD223) leads to a distinct pattern of chemokine and chemokine receptor expression by human dendritic cells. Vaccine. 2003 Feb 14;21(9-10):862-8. doi: 10.1016/s0264-410x(02)00533-9.
PubMed 12547595Andreae S, Buisson S, Triebel F. MHC class II signal transduction in human dendritic cells induced by a natural ligand, the LAG-3 protein (CD223). Blood. 2003 Sep 15;102(6):2130-7. doi: 10.1182/blood-2003-01-0273. Epub 2003 May 29.
PubMed 12775570El Mir S, Triebel F. A soluble lymphocyte activation gene-3 molecule used as a vaccine adjuvant elicits greater humoral and cellular immune responses to both particulate and soluble antigens. J Immunol. 2000 Jun 1;164(11):5583-9. doi: 10.4049/jimmunol.164.11.5583.
PubMed 10820232Prigent P, El Mir S, Dreano M, Triebel F. Lymphocyte activation gene-3 induces tumor regression and antitumor immune responses. Eur J Immunol. 1999 Dec;29(12):3867-76. doi: 10.1002/(SICI)1521-4141(199912)29:123.0.CO;2-E.
PubMed 10601994Cappello P, Triebel F, Iezzi M, Caorsi C, Quaglino E, Lollini PL, Amici A, Di Carlo E, Musiani P, Giovarelli M, Forni G. LAG-3 enables DNA vaccination to persistently prevent mammary carcinogenesis in HER-2/neu transgenic BALB/c mice. Cancer Res. 2003 May 15;63(10):2518-25.
PubMed 12750275Di Carlo E, Cappello P, Sorrentino C, D'Antuono T, Pellicciotta A, Giovarelli M, Forni G, Musiani P, Triebel F. Immunological mechanisms elicited at the tumour site by lymphocyte activation gene-3 (LAG-3) versus IL-12: sharing a common Th1 anti-tumour immune pathway. J Pathol. 2005 Jan;205(1):82-91. doi: 10.1002/path.1679.
PubMed 15586367Huard B, Tournier M, Hercend T, Triebel F, Faure F. Lymphocyte-activation gene 3/major histocompatibility complex class II interaction modulates the antigenic response of CD4+ T lymphocytes. Eur J Immunol. 1994 Dec;24(12):3216-21. doi: 10.1002/eji.1830241246.
PubMed 7805750Hannier S, Tournier M, Bismuth G, Triebel F. CD3/TCR complex-associated lymphocyte activation gene-3 molecules inhibit CD3/TCR signaling. J Immunol. 1998 Oct 15;161(8):4058-65.
PubMed 9780176Workman CJ, Vignali DA. The CD4-related molecule, LAG-3 (CD223), regulates the expansion of activated T cells. Eur J Immunol. 2003 Apr;33(4):970-9. doi: 10.1002/eji.200323382.
PubMed 12672063
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Soluble LAG-3 (IMP321) and Gemcitabine in Patients With Advanced Pancreas Cancer
- ClinicalTrials.gov ID
- NCT00732082
- Acronym / sponsor ID
- 07-0265
- Conditions
- Pancreatic Neoplasms
- Keywords
- LAG-3 and gemcitabine treatment for advanced pancreas cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company manufacturing study drug was unable to continue production.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Aug 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.
The overall purpose of this research is to evaluate the safety and toxicity of an investigational medication, IMP321, in patients being treated with gemcitabine. IMP321 is a synthetic protein (made in the laboratory to simulate a protein that your body makes on its own) and was designed to stimulate the immune system with the overall objective of improving the body's capacity to react to your pancreas cancer.
Detailed description
This is a phase I, single center, open label, non-randomized, dose-escalation phase I study performed in the ambulatory setting in patients receiving first line chemotherapy for unresectable pancreas cancer with gemcitabine weekly and the investigational agent IMP321. IMP321 will be given at D2 and D16 of a 4-week cycle, for a period of 6 months. The hypothesis of this study is that IMP321 is safe for human administration. Additionally we hypothesize that IMP321 elicits an immunomodulatory effect that is therapeutic in the treatment of pancreas cancer.
Primary Objectives
- To evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in patients being treated with gemcitabine for advanced pancreas cancer.
- To determine any dose limiting toxicities of IMP321 in patients being treated with gemcitabine for advanced pancreas cancer.
Secondary Objectives
- To describe the pharmacokinetics of the last IMP321 subcutaneous injection compared to the first one, in a limited number of patients.
- To determine the pharmacodynamics of IMP321 therapy by:
- Quantify peripheral blood Treg (CD4+CD25+FoxP3+ T cells) in pancreatic cancer patients before and during treatment with IMP321 by flow cytometry.
- Evaluate the B- and T-cell responses to the pancreatic cancer-expressed antigen, mesothelin, by testing for antibodies and T-cell response by ELISpot.
- To evaluate the clinical response and time to disease progression with computed tomography examinations at two month intervals (current standard of care in gemcitabine-treated patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 0 | Active comparator | Drug: GemcitabineGemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle. |
| Dose Level 1 | Experimental | Drug: Gemcitabine, Biological: LAG-3Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle. IMP321 3 mg SQ anterior surface of either the right or left thigh on Day 2. The subsequent doses will be given by subcutaneous injection on the contralateral thigh. Each single injection will be separated by a 13-day administration free period. |
| Dose Level 2 | Experimental | Drug: Gemcitabine, Biological: LAG-3Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle. IMP321 6.5 mg SQ anterior surface of either the right or left thigh on Day 2. The subsequent doses will be given by subcutaneous injection on the contralateral thigh. Each single injection will be separated by a 13-day administration free perio |
| Dose Level 3 | Experimental | Drug: Gemcitabine, Biological: LAG-3Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle. IMP321 13 mg SQ anterior surface of either the right or left thigh on Day 2. The subsequent doses will be given by subcutaneous injection on the contralateral thigh. Each single injection will be separated by a 13-day administration free perio |
| Dose Level 4 | Experimental | Drug: Gemcitabine, Biological: LAG-3Gemcitabine (1 mg/m2 over 30 min) will be given on days 1, 8, and 15 of a 28 day cycle. IMP321 26 mg SQ anterior surface of either the right or left thigh on Day 2. The subsequent doses will be given by subcutaneous injection on the contralateral thigh. Each single injection will be separated by a 13-day administration free perio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must have a newly diagnosed, histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma (primary tumor or metastasis). The histological slides or blocks must be available for review.
- Patient must have advanced disease (characterized by metastasis or locally advanced disease), or unable to undergo surgical treatment due to extent of disease or pre-existing health conditions precluding surgical treatment.
- Measurable or evaluable disease: RECIST Criteria will be used to assess and survey extent of disease
- Patients must be ≥ 18 years old.
- Performance Status: Karnofsky Performance Status (KPS) ≥ 70
Key exclusion criteria (4 listed)
- Patient is currently receiving other investigational agents.
- Pregnant and nursing women patients are not eligible.
- Patients known to be HIV (patient self-report) positive are ineligible because of the potential inability to modulate immune responses.
- Patients with a QTc of >460 msec.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | Dose Level 0, Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
| LAG-3 | Biological | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
Primary outcome
To evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in patients being treated with gemcitabine for advanced pancreas cancer.
Time frame: 6 months
To determine the dose limiting toxicities of IMP321 in patients being treated with gemcitabine for advanced pancreas cancer.
Time frame: 6 months
3 secondary outcomes
To describe the pharmacokinetics of the last IMP321 subcutaneous injection compared to the first one, in a limited number of patients.
Time frame: Pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours, and 96 hours after IMP321 administration
To determine the pharmacodynamics of IMP321 therapy
Time frame: 6 months
To evaluate the clinical response and time to disease progression with computed tomography examinations at two month intervals (current standard of care in gemcitabine-treated patients).
Time frame: survival
Results and safety
The study was stopped early (reason given: Company manufacturing study drug was unable to continue production.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Background: PubMed 9194473Storniolo AM, Allerheiligen SR, Pearce HL. Preclinical, pharmacologic, and phase I studies of gemcitabine. Semin Oncol. 1997 Apr;24(2 Suppl 7):S7-2-S7-7.
- Background: PubMed 8893879Green MR. Gemcitabine safety overview. Semin Oncol. 1996 Oct;23(5 Suppl 10):32-5.
- Background: PubMed 9196156Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
- Background: PubMed 16106066Linehan DC, Goedegebuure PS. CD25+ CD4+ regulatory T-cells in cancer. Immunol Res. 2005;32(1-3):155-68. doi: 10.1385/IR:32:1-3:155.
- Background: PubMed 12193750Liyanage UK, Moore TT, Joo HG, Tanaka Y, Herrmann V, Doherty G, Drebin JA, Strasberg SM, Eberlein TJ, Goedegebuure PS, Linehan DC. Prevalence of regulatory T cells is increased in peripheral blood and tumor microenvironment of patients with pancreas or breast adenocarcinoma. J Immunol. 2002 Sep 1;169(5):2756-61. doi: 10.4049/jimmunol.169.5.2756.
- Background: PubMed 14644131Triebel F. LAG-3: a regulator of T-cell and DC responses and its use in therapeutic vaccination. Trends Immunol. 2003 Dec;24(12):619-22. doi: 10.1016/j.it.2003.10.001.
- Background: PubMed 12547595Buisson S, Triebel F. MHC class II engagement by its ligand LAG-3 (CD223) leads to a distinct pattern of chemokine and chemokine receptor expression by human dendritic cells. Vaccine. 2003 Feb 14;21(9-10):862-8. doi: 10.1016/s0264-410x(02)00533-9.
- Background: PubMed 12775570Andreae S, Buisson S, Triebel F. MHC class II signal transduction in human dendritic cells induced by a natural ligand, the LAG-3 protein (CD223). Blood. 2003 Sep 15;102(6):2130-7. doi: 10.1182/blood-2003-01-0273. Epub 2003 May 29.
- Background: PubMed 10820232El Mir S, Triebel F. A soluble lymphocyte activation gene-3 molecule used as a vaccine adjuvant elicits greater humoral and cellular immune responses to both particulate and soluble antigens. J Immunol. 2000 Jun 1;164(11):5583-9. doi: 10.4049/jimmunol.164.11.5583.
- Background: PubMed 10601994Prigent P, El Mir S, Dreano M, Triebel F. Lymphocyte activation gene-3 induces tumor regression and antitumor immune responses. Eur J Immunol. 1999 Dec;29(12):3867-76. doi: 10.1002/(SICI)1521-4141(199912)29:123.0.CO;2-E.
- Background: PubMed 12750275Cappello P, Triebel F, Iezzi M, Caorsi C, Quaglino E, Lollini PL, Amici A, Di Carlo E, Musiani P, Giovarelli M, Forni G. LAG-3 enables DNA vaccination to persistently prevent mammary carcinogenesis in HER-2/neu transgenic BALB/c mice. Cancer Res. 2003 May 15;63(10):2518-25.
- Background: PubMed 15586367Di Carlo E, Cappello P, Sorrentino C, D'Antuono T, Pellicciotta A, Giovarelli M, Forni G, Musiani P, Triebel F. Immunological mechanisms elicited at the tumour site by lymphocyte activation gene-3 (LAG-3) versus IL-12: sharing a common Th1 anti-tumour immune pathway. J Pathol. 2005 Jan;205(1):82-91. doi: 10.1002/path.1679.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
William G. Hawkins, M.D. principal investigator
Washington Univerisity
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 Gemcitabine and LAG-3 in people with Pancreatic Neoplasms, run by Washington University School of 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 17 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Jun 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 was stopped early (reason given: Company manufacturing study drug was unable to continue production.). Results are not available in the source record.
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 evaluate the safety and tolerability of repeated IMP321 subcutaneous injections in patients being treated with gemcitabine for advanced pancreas cancer. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00732082, which also lists 28 linked publications.
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 12 Jun 2013.