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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.

Outcome Description:

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.

Outcome Time Frame:

5 injections, treatment period 36 days

Safety Issue:

No

Principal Investigator

Tone Nordøy, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tromsø University Hospital

Authority:

Norway: Norwegian Medicines Agency

Study ID:

C09-315-02

NCT ID:

NCT01223209

Start Date:

August 2010

Completion Date:

January 2012

Related Keywords:

  • Carcinoma
  • Cancer
  • Carcinoma
  • Curative surgery
  • Curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start
  • Carcinoma

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