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New treatment option for Stage IV Colorectal Cancer
Official title Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
ClinicalTrials.gov ID: NCT02919644
What this study is testing
What is autologous dendritic cells loaded with autologous tumour homogenate?
autologous dendritic cells loaded with autologous tumour homogenate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stage iv colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent.
- The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of Istituto Scientifico Romagnolo per lo Studio e...
- The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the...
- The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery.
- Age \>18 years.
You likely can't join if
- Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- Patients who relapsed within 6 months since primary treatment of stage I-III colorectal cancer. If adjuvant chemotherapy had been administered, the...
- Patient who completed surgery more than 60 days before study enrolment.
- History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri...
- History of congenital or acquired immunodeficiency, including history of organ transplantation.
- Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti-HBs antibodies and anti-hepatitis B core (HBc)...
See the full eligibility criteria
- Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent.
- The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS) and must fulfil all the acceptance...
- The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions had occurred in other sites, these must be also included...
- The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery.
- Age \>18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patient must have acceptable organ function, defined as:
- Haemoglobin \>10 g/dl
- White blood cells ≥4000/μl.
- Absolute neutrophil count \>1500/μl.
- Platelets ≥100000/μl.
- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) \<3 times the upper institutional reference level.
- Total bilirubin \<1.5 times the upper institutional reference level.
- Serum creatinine \<1.5 times the upper institutional reference level.
- Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.
- Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of \<1% per year: double barrier method, one barrier...
- The patient is willing and able to give written informed consent for the study.
- Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- Patients who relapsed within 6 months since primary treatment of stage I-III colorectal cancer. If adjuvant chemotherapy had been administered, the term must be computed since last chemotherapy dose.
- Patient who completed surgery more than 60 days before study enrolment.
- History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.
- History of congenital or acquired immunodeficiency, including history of organ transplantation.
- Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti-HBs antibodies and anti-hepatitis B core (HBc) antibodies), hepatitis C virus (HCV), HIV or Treponema pallidum. The serologic...
- Female patients who are pregnant or nursing.
- Patients undergone surgery after preoperatory chemotherapy with a fluoropyrimidine plus oxaliplatin, unless they are not candidate for postoperatory chemotherapy with the same schedule in the opinion of the Investigator...
- Participation in another clinical trial with any investigational agent within 30 days prior to study screening.
- Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement...
- Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukapheresis. In addition, all patients aged 70 or older must be evaluated by a...
- Any clinical condition that, in the opinion of the Investigator, contraindicates the subcutaneous administration of low-dose IL-2 as per protocol (see section 6.2 for details).
- Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social...
- Refusal of giving written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Meldola, FC, Italy
- Aviano, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meldola, FC, Italy; Aviano, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.