Health Condition 1: C56- Malignant neoplasm of ovary
Conditions
Interventions
Intervention1: 1 ââ?¬â?? Metronomic chemotherapy with placebo (saline given intradermally)
2 ââ?¬â?? Metronomic chemotherapy with DCs primed with recombinant SPAG9 protein, given intradermally: 1. M
Capecitabine 500mg/day from day 7 to day 97
cisplatinum 40 mg/m2 on days 98 and day 112. Restart cyclophosphamide and capecitabine from day 158 if patient in iCR, iPR, iSD and continue till day 280.
In addition, patients will receive 0.5 mL sal
Sponsors
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who have failed at least two systemic therapies [in platinum sensitive ((â�¥ 1 year of Platinum-free interval (PFI)) or platinum partially sensitive (those having a PFI of â�¥ 6 months but less than a year) in epithelial ovarian cancers of stage I, II, III or IV 2. Patients in the age group of 18-65 years 3. Histologically confirmed diagnosis of epithelial ovarian cancer 4. Performance status - ECOG 0-2 5. No allergy to components of the DCs 6. Normal baseline hematological parameters (within 1 week before first vaccination): hemoglobin â�¥ 9.5 g/dl; total granulocyte count > 1000/�¼l; platelet count â�¥ 100,000 /�¼l; BUN 60 ml/minute; alkaline phospatase; aspartate aminotransferase less than thrice the upper limit of normal; and a prothrombin time no greater than 1.4 times control, unless therapeutically warranted 7. No contraindications for chemotherapy with cyclophosphamide, capecitabine or cisplatin. 8. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study and willing to participate in the study 9. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 10. Should have evaluable disease by clinical and/or imaging using iRECIST criteria 11. Should have completed at least 4 weeks after surgery and >3 weeks after last chemotherapy 12. Tumors should be SPAG9 positive by IHC or flowcytometry
Exclusion criteria
Exclusion criteria: 1. Platinum refractory/resistant epithelial ovarian cancers and or massive [�10 cm at single sites] resistant abdominal/pelvic disease 2. HIV or Hepatitis B or C infection 3. Patients with history of auto-immune disease 4. Pregnancy 5. Severe pulmonary or cardiac disease [Ejection Fraction �50%] or NYHA Class 3 or 4 6. Uncontrolled diabetes or hypertension 7. Presence of acute infection requiring treatment 8. Patients on immunosuppressive drugs including steroids; if patient had been on steroids, it should have been stopped at least 4 weeks prior to inclusion in the study 9. Unwillingness to use a medically accepted form of birth control during the study 10. Patients with brain or spinal metastasis; patients with life threatening visceral metastasis and disease sites such as major vessel involvement, tracheal involvement etc. Patients with features suggestive of sub-acute intestinal obstruction will be excluded 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study 12. Sensory or motor neuropathy of grade 2 or above 13. Sensorineural hearing loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Immune-related Disease control rate(iCR,iPR,iSD) at 22 weeks 2.Immune related Progression free survival (irPFS) at 22 weeks Timepoint: 22 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Immune-related disease control rate(iCR,iPR,iSD) at 40 weeks 2.Immune-related Progression free survival at 40 weeks 3.Immune-related Best overall response(irBOR) 4. Assessment of immune response 5.Overall Survival (OS) 6.Assessment of safety and tolerability Timepoint: 40 weeks | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
Cancer Institute (WIA)
Outcome results
None listed