EGF-based vaccine with VChTV Schedule in hormone-refractory prostate tumors

Clinical evaluation of the VChTV Schedule with the EGF-based vaccine the treatment of patients suffering hormone-refractory prostate tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000159

Enrollment

212

Registered

2013-06-19

Start date

2006-04-19

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone-refractory prostate tumors

Interventions

Study Group (Vaccine EGF): Vaccine in schedule Vaccine-Chemotherapy-Vaccine (VChTV) Day 1 Cyclophosphamide 200 mg/m2 by intravenous route. Day 4 EGF vaccine 2.4 mg by intramuscular route quarterly up

Eligibility

Sex/Gender

Male

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who accomplished the diagnosis criteria. 2. Patients Oldest than 18 years. 3. Patients who sign the Informed Consent 4. Patients with measured lesions or valuable. 5. Patients with serum levels of testosterone equal = 30 ng/ml. 5. Patients with general performance status according ECOG <2. 6. Patients with life expectancy over 6 months. 7. Patients with an adequate function of organs and bone marrow.. 8. Patients who finalized the hormone therapeutic maneuvers 6 to 8 weeks before the recruitment.

Exclusion criteria

Exclusion criteria: 1. Patients who are receiving another onco-specific product on research. 2. Patients with personal history of allergy related with compounds of similar chemical composition as the studied EGF. 3. Patients with personal history of hyper- sensibility to antracyclines and/or mitroxantrone. 4. Patients suffering of concomitant non controlled diseases including: active infections, symptomatic congestive heart failure, instable cardiac angina, cardiac arrhythmias, liver diseases and psychiatric disorders that limits the adherence to the clinical trial requirements. 5. Patients with brain metastases 6. Patients positive to HIV

Design outcomes

Primary

Measure	Time frame
Survival (Alive, Dead). Measuring time: 24 months Immunogenicity (Anti-EGF antibodies titers and EGF sera concentration). Measuring time: in each immunization	—

Secondary

Measure	Time frame
Adverse events (Name, Intensity, SAE, Vaccine related Death). Measuring time: in every immunization and in every cycle of chemotherapy Quality of Life (EORTC QLQ-C30). Measuring time: Every 6 months	—

Countries

Cuba

Contacts

Public ContactPedro Rodriguez Rodriguez

Centre of Molecular Immunology

camilo@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026