Status:
COMPLETED
Bcl-XL_42-CAF09b Vaccination for Patients With Prostate Cancer With Lymph Node Metastases
Lead Sponsor:
Herlev Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node metastases are treated with the cancer vaccine Bcl-xl\_42-CAF09b. The aim of the study is to clarify the safe...
Detailed Description
Background: In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node metastases are treated with the cancer vaccine Bcl-xl\_42-CAF09b. The aim of the study is to cla...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically Verified Adenocarcinoma Prostatae
- Diagnostic and / or histologically verified lymph node metastases
- ECOG Performance Status ≤2
- Primary anti-androgen treatment started
- Adequate haematological, renal and hepatic function:
- Neutrophil granulocytes ≥ 1.5 x 109 / l
- Platelet counts ≥ 100 x 109 / l
- hemoglobin ≥ 5.6 mmol / l
- Serum creatinine ≤ 1.5 times upper normal limit
- AST or ALAT ≤ 2.5 times upper normal limit
- serum bilirubin ≤ 1.5 times upper normal limit
- Alkaline phosphatase ≤ 2.5 times upper normal limit
- INR \<1.5 / PP \<40
Exclusion
- Verified bone or visceral metastases
- Serious allergy or previous anaphylactic reactions
- Known hypersensitivity to any of the active substances or to any of the excipients.
- Other malignant disease within the last three years, rendering planocellular and basocellular skin carcinoma
- Known infection with HIV, hepatitis B and C virus, regardless of whether the infection is kept calm with medical treatment
- Severe medical disorder, severe asthma, severe COPD, poorly regulated cardiovascular disease or diabetes
- Active autoimmune disease, e.g. autoimmune neutropenia / thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, goodpasture syndrome, Addison's disease, Hashimoto's thyroiditis, active grave disease, morbus chrohn or ulcerative colitis
- Major gastrointestinal surgical procedures within the last 3 months
- Previous treatment with other cancer vaccine
- Concomitant immunosuppressive treatment including prednisolone and methotrexate
- Ongoing anticoagulant treatment (treatment with acetylsalicylic acid and clopidogrel is allowed)
- Psychiatric disease which, according to the investigator's discretion, may affect compliance
- Co-administration with other experimental drugs.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03412786
Start Date
May 1 2018
End Date
December 8 2021
Last Update
January 11 2022
Active Locations (1)
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1
Herlev Hospital
Herlev, Denmark, 2730