A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
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|ClinicalTrials.gov Identifier: NCT01223209|
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : January 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma||Drug: LTX-315||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001.
0.25-2.0 mg/ML, maximum 5 injections during 36 days.
Other Name: GV-1001
- Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood. [ Time Frame: 5 injections, treatment period 36 days ]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.
- To evaluate the safety profile of LTX-315 in combination with GV1001 study [ Time Frame: 5 injections, treatment period 36 days ]Assessment of adverse events and abnormal laboratory values recorded during the
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223209
|University Hospital North-Norway|
|Tromsø, Norway, 9038|
|Principal Investigator:||Tone Nordøy, MD, PhD||Tromsø University Hospital|