| General information |
| Database: | DB00720 |
| Objective: | The primary objective of the ongoing LICC trial (LBLP25 In Colorectal Cancer) is to determine whether LBLP25, an active cancer immunotherapy, extends recurrencefree survival (RFS) time over placebo in colorectal cancer patients following R0/R1 resection of hepatic metastases. |
| Authors: | Schimanski CC, et al |
| Title: | LICC: LBLP25 in patients with colorectal carcinoma after curative resection of hepatic metastases: a randomized, placebocontrolled, multicenter, multinational, doubleblindedphase II trial. |
| Journal: | BMC Cancer. |
| Year: | 2012 |
| PMID: | 22494623 |
| Trial Design |
| Clinical Trial Id: | EudraCT Number 201100021820. |
| Agent: | LBLP25
|
| Target: | MUC1 glycoprotein
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | colorectal cancer liver metastasis |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multinational, phase II, multicenter, randomized, doubleblind, placebocontrolled trial |
| Key Patients Feature: | Signed written informed consent. Male or female. At least 18 years of age. Female patients of childbearing potential (and if appropriate male patients with female partners of childbearing potential) must be willing to usean adequate method of contraception for 4 weeks prior to, during and 12 weeks after the last dose of trial medication. A negative pregnancy test isrequired for female subjects. Adequate contraception for female subjects is defined as two barrier methods, or one barrier method with aspermicide, or intrauterine device or use of hormonal female contraceptive. For the purpose of this trial, women of childbearing potential aredefined as: ¡°All female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive.¡± Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with complete resection of primary tumor and no evidence of localrelapse. Metastatic disease of the liver, with recent (< 6 weeks prior to randomization) resection (R0 or R1) of all liver metastases. Metastasectomy may havebeen either synchronous or metachronous. Any neoadjuvant therapy may have been applied for maximal 3 months prior to metastasectomy. Subject has had a colonoscopy or rectoscopy within the last three months prior to initiation of therapy Subject has an ECOG performance status of 0 or 1. Subject has adequate hematologic, hepatic, and renal function within 2 weeks prior to initiation of therapy as defined by the following: Absolute neutrophils > 1, 500/mm3 and platelets > 140, 000/mm3. Bilirubin < 1.5 ¡Á upper limit of normal (ULN). AST and ALT < 2.5 ¡Á ULN. Creatinine < 1.5 ¡Á ULN. International Normalized Ratio (INR) and partial thromboplastin time (PTT) in the normal range of the local lab. Willingness to comply with study protocol requirements. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | LBLP25 VS placebo |
| Treatment Info: | eligible patients are randomized 2:1 to receive either LBLP25 or placebo. Those allocated to LBLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first LBLP25 dose, then primary treatment with s.c. LBLP25 930 ¦Ìg once weekly for 8 weeks, follotheyd by s.c. LBLP25 930 ¦Ìg maintenance doses at 6week (years 1&2) and 12week (year 3) intervals unless recurrence occurs. In the control arm, CP is replaced by saline solution and LBLP25 by placebo. |
| Primary End Point: | recurrencefree survival (RFS) time between groups |
| Secondary End Point: | overall survival (OS) time, safety, tolerability, RFS/OS |
| Patients Number: | 159 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | The design and implementation of such a vaccination study in colorectal cancer is feasible. The study will provide recurrencefree and overall survival rates of groups in an unbiased fashion. |