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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma
• Intervention / Treatment: Drug: LTX-315

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 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway, 9038
    • University Hospital North-Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LTX-315; The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001.	Drug: LTX-315; 0.25-2.0 mg/ML, maximum 5 injections during 36 days.; Other Names: GV-1001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lytix Biopharma AS
• Collaborators: Kael-GemVax Co., Ltd.
• Investigators: Principal Investigator: Tone Nordøy, MD, PhD, Tromsø University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Cancer; Carcinoma; Curative surgery; Curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: C09-315-02