Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
This trial is active, not recruiting.
|Condition||pancreatic cancer, resected|
|Phase||phase 1/phase 2|
|Start date||December 2012|
|End date||June 2018|
|Trial size||32 participants|
|Trial identifier||NCT02261714, CT TG01-01|
The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and
- Understand any possible side effects of the additional use of TG01/GM-CSF with gemcitabine
- Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune response
- Investigate if the treatment can delay or reduce recurrence of the disease
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Oslo, Norway||Oslo University Hospital HF the Norwegian Radium Hospital||no longer recruiting|
|Madrid, Spain||Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro||no longer recruiting|
|Birmingham, United Kingdom||Queen Elizabeth University Hospital / Edgaston /||no longer recruiting|
|Liverpool, United Kingdom||University of Liverpool / Molecular and Clinical Cancer Medicine||no longer recruiting|
|Manchester, United Kingdom||University of Manchester / The Christie NHS Foundation Trust||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Patients' safety during study
time frame: 2 years
Patients' Immune response
time frame: During the 2 years of treatment
time frame: 2 years
Male or female participants from 18 years up to 99 years old.
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
- Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
- Successful surgical resection
- Complete resection (R0) or with microscopic residual disease (R1)
- Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
- Laboratory Values:
- Absolute neutrophil count ≥ 1.5 x 10^9/l
- Platelets ≥100 x 10^9/l
- Haemoglobin ≥ 9 g/dl
- Total bilirubin ≤ 1.5 x UNL
- Serum creatinine ≤ 1.5 x UNL
- Albumin ≥ 2.5 g/dl
- AST or ALT ≥ 5 x UNL
- 18 years of age or older.
- ECOG performance status (PS) of 0-1.
- Life expectancy of at least 6 months
- Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
- Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures
- Has received an investigational drug within 4 weeks prior to Trial drug administration
- Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy).
- Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma).
- Has any other serious illnesses or medical conditions such as, but not limited to:
- Any uncontrolled infection
- Uncontrolled cardiac failure classification III or IV (NY Heart Association)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- Bone marrow dysplasia
- History of auto-immune disease
- History of adverse reactions to vaccines
- Known history of positive tests for HIV/AIDS, hepatitis B or C
- Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
- Contraindication to gemcitabine treatment
- Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
- Known malignant brain lesion(s)
- Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
- Are not expected to complete 6 cycles of chemotherapy
- Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study
|Official title||A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas|
|Principal investigator||Daniel PALMER|
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