vaccination study in patients with advanced MSI-H colorectal cancer

• Conditions: advanced MSI-H colorectal cancer; MedDRA version: 14.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000765-12-DE
• Lead Sponsor: Oryx GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Histologically confirmed, surgically resected colorectal cancer of advanced stage (UICC stage III/UICC stage IV). This comprises patients with lymph node metastases (UICC stage III), metastasis to one distant organ (UICC IV, M1a), to more than one distant organ, or patients with peritoneal carcinosis (M1b)
•Detection of high level microsatellite instability (MSI-H) in the resected tumor sample according to the international consensus criteria (multiplex PCR of quasi-monomorphic microsatellite markers BAT25, BAT26, CAT25), see Appendix 1.
•Prior adjuvant standard therapy (chemotherapy with 5-fluorouracil/folinic acid, oxaliplatin, irinotecan or combinations of these)
OR
Prior palliative standard therapy in the first, second and third line (chemotherapy with 5-fluorouracil, oxaliplatin, irinotecan or combinations of these and/or treatment with anti-EGFR antibodies cetuximab or panitumumab alone or in combination with chemotherapy) with either complete or partial remission, stable disease, or disease progression under therapy;
OR
Patient has refused adjuvant or palliative standard therapy (chemotherapy using 5-fluorouracil, oxaliplatin, or regimens combining these).
•Expected survival of at least six months.
•Full recovery from surgery or radiation therapy
•ECOG performance status 0, 1 or 2.
•The following laboratory results:
Neutrophil count> 1.5 x 109/L
Lymphocyte count > 0.5 x 109/L
Platelet count> 100 x 109/L
Serum bilirubin< 2mg/dL
•Male or female patients = 18 years old
•Last therapy discontinued at least 4 weeks prior to vaccination.
•Patient´s written informed consent for participation in the trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

•Prior treatment with FSPs AIM2(-1), HT001(-1) and TAF1B(-1)
•Clinically significant heart disease (NYHA Class IV).
•Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders.
•History of immunodeficiency disease or autoimmune disease.
•Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
•HBV, HCV or HIV positivity.
•Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
•Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
•Participation in any other clinical trial
•Pregnancy or lactation.
•Women of childbearing potential who are not using a medically acceptable means of contraception. Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
•Psychiatric or addictive disorders that may compromise the ability to give informed consent.
•Lack of availability of a patient for immunological and clinical follow-up assessment.
•Brain metastases (symptomatic and non-symptomatic)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified