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

NCT01639885 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-01-07

No results posted yet for this study

Summary

This study investigates the feasibility and immunogenicity of the triple combination of gemcitabine, Peg-Intron and p53 SLP vaccination in patients with platinum-resistant ovarian cancer.

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.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Judith R Kroep, MD, PhD · Leiden University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639885 on ClinicalTrials.gov