Status:
COMPLETED
A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
Lead Sponsor:
Lytix Biopharma AS
Collaborating Sponsors:
Kael-GemVax Co., Ltd.
Conditions:
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour. GV1001 is...
Detailed Description
This clinical study has two main aims which are: * To measure the immunological effects of LTX-315 in combination with GV1001 * Find out about the side effects of the combination of the two drugs Thi...
Eligibility Criteria
Inclusion
- Curative surgery for carcinoma performed at least three months prior to treatment start
- Age ≥18 years
- ECOG Performance status (PS): 0
- Life expectancy: at least 3 months
- Laboratory requirements:
- White Blood Count (WBC) ≥ 3 x 109/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Haemoglobin ≥ 10.0 g/dL
- Total bilirubin level ≤ 1.5 ULN
- AST and ALT ≤ 2.5 x ULN
- Creatinine ≥ 1.5 ULN
- Albumin \> 30 g/L
- No expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted
- Must be willing to practice acceptable barrier methods of birth control to prevent pregnancy
- The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination
- The patient has been fully informed about the study and has signed the informed consent form
Exclusion
- Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period
- Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents
- Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (\< Grade 1) due to agents administered more than 4 weeks earlier
- Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events
- Is currently on any agent with a known effect on the immune system
- Has any other serious illness or medical condition such as but not limited to:
- Any uncontrolled infection or infection requiring antibiotics
- Uncontrolled cardiac failure Classification III or IV (New York Heart Association)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- Bone marrow dysplasia
- History of auto-immune disease
- History of adverse reaction to vaccines
- Known history of positive tests for HIV/AIDS, hepatitis B or C
- Is pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01223209
Start Date
August 1 2010
End Date
January 1 2012
Last Update
January 11 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital North-Norway
Tromsø, Norway, 9038