Chemo-immunotherapy (Gemcitabine, Interferon-alpha 2b and p53 SLP) in Patients With Platinum-resistant Ovarian Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

January 31, 2014

Conditions
Recurrent Ovarian Cancer
Interventions
DRUG

Interferon Alfa-2b

1ug/kg (max 100ug) 7 days before and 22 days after first treatment with gemcitabine

DRUG

Interferon Alfa-2b

1ug/kg (max 100ug) 7 days before and 22 days after first treatment with gemcitabine

BIOLOGICAL

p53 SLP

8.2.3 The p53 SLP vaccine consists of 9 synthetic 25-30 amino acids long overlapping peptides, spanning amino acids 70-235 of the wt-p53 protein (patent number WO2008147186). Peptides are prepared at the GMP facility of the Department of Clinical Pharmacy and Toxicology of the LUMC. At the day of immunization peptides (0.3 mg/peptide) were dissolved in dimethyl sulfoxide (DMSO, final concentration 20%) admixed with 20 mM phosphate buffer (pH7.5) and emulsified with an equal volume of Montanide ISA-51.The vaccine (2.7mL) is administered subcutaneously.

Trial Locations (1)

2333 ZA

Leiden University Medical Center, Leiden

All Listed Sponsors
collaborator

University Medical Center Groningen

OTHER

lead

Leiden University Medical Center

OTHER

NCT01639885 - Chemo-immunotherapy (Gemcitabine, Interferon-alpha 2b and p53 SLP) in Patients With Platinum-resistant Ovarian Cancer | Biotech Hunter | Biotech Hunter