A phase I-IIa clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced cancer

Phase 1

• Conditions: Advanced solid tumors; MedDRA version: 16.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002663-25-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-18
• Study Completion: 2020-01-01
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

-Histologically confirmed advanced, solid malignancy.
-Refractory or not amenable to standard therapy
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
-Willing and able to give written informed consent
-Patient is = 18 years of age at the time of signature of the informed consent
-Adequate hematological function: Absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, Hemoglobin = 6.0 mmol/L.
-Adequate hepatic function: serum bilirubin = 1.5 times the upper limit of normal (ULN), ALT and AST = 2.5 x ULN (or = 5 times ULN if liver metastases are present).
-Adequate renal function: eGFR = 50ml/min
-Female patients of childbearing potential may be enrolled in the study, if the patient
oHas practiced adequate contraception for 30 days prior to first hVEGF26-104/RFASE administration.
oNegative pregnancy test
oHas agreed to continue adequate contraception for as long as VEGF is neutralized.
-Part 2 only:
oHistological confirmed advanced colorectal cancer
oPlanning to initiate treatment with irinotecan or
oPlanning to initiate second line treatment with the XELOX regimen after progression on first line treatment with XELOX combined with bevacizumab.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Major surgery within 28 days before the initiation of study treatment
-Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment.
-Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment.
-Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
-The patient is scheduled to receive another vaccination during the DLT period.
-A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis.
-Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment.
-Primary or secondary immunodeficiency
-Treatment with a glucocorticoid derivative in an equivalent dose of = 10mg prednisone a day.
-Female patients: the patient is pregnant or lactating.
-Part 1 only:
oWhen the patient is scheduled to receive any other anticancer treatments than those specified in the protocol.
oChemotherapy within 28 days prior to the initiation of study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified