A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma

Carcinoma Clinical Trial

Official title:

A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223209
• Other study ID #: C09-315-02
• Status: Completed
• Phase: Phase 1
• First received: October 14, 2010
• Last updated: January 10, 2012
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Lytix Biopharma AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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 a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001.

LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.

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 This is an open label, single centre study assessing immunological effects and safety of LTX-315 given as an adjunct to GV1001. The LTX-315 dose will escalate while the GV1001 dose will be fixed.

LTX-315 and GV1001 will be given as intradermal injections on days 1, 8, 15, 22 and 36.

Investigational treatment: LTX-315 (0.10 mL) with escalating concentrations will be injected intradermally, followed, 1-2 hours later, by intradermal injection of 0.56 mg GV1001 (0.20 mL, 2.8 mg/mL) in the same site, in one arm.

DTH-test control: 0.10 mg GV1001 (0.10 mL) will be injected intradermally in the contralateral arm without LTX-315, as a DTH skin reactivity test control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma

Intervention

Drug:
• LTX-315
0.25-2.0 mg/ML, maximum 5 injections during 36 days.

Locations

Country	Name	City	State
Norway	University Hospital North-Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
Lytix Biopharma AS	Kael-GemVax Co., Ltd.

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.	Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.	5 injections, treatment period 36 days	No
Secondary	To evaluate the safety profile of LTX-315 in combination with GV1001 study	Assessment of adverse events and abnormal laboratory values recorded during the	5 injections, treatment period 36 days	No