NCT01223209

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

October 14, 2010

Last Update Submit

January 10, 2012

Conditions

Carcinoma

Keywords

CancerCarcinomaCurative surgeryCurative surgery for carcinoma at least three months and not more than 5 years prior to treatment start

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the safety profile of LTX-315 in combination with GV1001 study

    5 injections, treatment period 36 days

Study Arms (1)

LTX-315

EXPERIMENTAL

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

Interventions

LTX-315DRUG

0.25-2.0 mg/ML, maximum 5 injections during 36 days.

Also known as: GV-1001
LTX-315

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital North-Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

CarcinomaNeoplasms

Interventions

LTX-315GV1001 peptide

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Tone Nordøy, MD, PhD

    Tromsø University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 18, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

NO(1)