Clinical trial · Interventional
Chemo-immunotherapy (Gemcitabine, Interferon-alpha 2b and p53 SLP) in Patients With Platinum-resistant Ovarian Cancer
Chemo-Immunotherapy, Gemcitabine With Pegylated Interferon Alpha-2b (Peg-Intron) With and Without p53 Synthetic Long Peptide (p53 SLP) Vaccine, for Patients With Platinum Resistant Ovarian Cancer CHIP Trial
NCT01639885CI-TRIAL-00013345CHIPcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon Alfa-2b | Drug | Interferon Alfa-2b | ALIAS |
| p53 SLP | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Group 1
- description
- Patients will receive standard care (gemcitabine)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients will receive standard care (gemcitabine) combined with interferon-alpha 2b (Peg-Intron)
- interventionNames
- Drug: Interferon Alfa-2b
- type
- EXPERIMENTAL
- label
- Group 3
- description
- Patients will receive standard care (gemcitabine) combined with interferon-alpha 2b (Peg-Intron) and p53 SLP vaccin
- interventionNames
- Drug: Interferon Alfa-2b
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven epithelial ovarian cancer, peritoneal cavity or fallopian tube cancer (inclusive mucinous or clear cell tumors) * Tumor over-expressing p53 * Progression of disease or relapse after previous therapy with platinum * Measurable disease (RECIST 1.1) or elevated CA125 \> 2 times the upper limit of normal within 3 months and confirmed * Age ≥ 18 years * WHO performance status 0-2 * Adequate bone marrow function: WBC ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l * Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤ 2.5 x UNL, Alkaline Phosphatase ≤5 x UNL * Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min * Survival expectation \> 3 months * Patients must be accessible for treatment and follow-up * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. * Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * Known hypersensitivity reaction to any of the components of the treatment * Pregnancy or lactating * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.