Status:
COMPLETED
Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Metastatic Breast Cancer
Malignant Melanoma
Eligibility:
All Genders
12-70 years
Phase:
PHASE2
Brief Summary
The present protocol is a phase 2 study designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors, similarly to the well established graft ...
Eligibility Criteria
Inclusion
- Consenting patients (age 12-70) will be eligible for participation in the study involving anti-tumor immunotherapy provided the following criteria are met:
- Evidence of cancer not expected to be cured with conventional modalities:
- Pediatric patients: Chemotherapy-resistant neuroblastoma stage 4 \& sarcomas. Adult patients: Metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovary cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, metastatic prostate cancer.
- Patients with measurable disease evaluable for response with anticipated life expectancy \>3 months.
- Patients must be \>2 weeks off anti-cancer or potentially immunosuppressive treatment.
- Adequate ambulatory performance status (Karnofsky \>80%; ECOG 0-1) to enable outpatient treatment (see Appendix 1).
- Compliant and cooperative patients anticipated to be evaluable for response according to investigator's assessment.
- HLA-noncompatible (partial matched or mismatched) donor available.
Exclusion
- Patients will be excluded from participation in the study if any of the following criteria are met:
- Any of the above criteria are not met.
- Patients with a significant history or current evidence of potentially severe cardiovascular disease.
- Hepatic and/or renal failure.
- Abnormal PT and PTT.
- Patients with abnormal hemogram (PMN\<1.0x109/L; HB\<10; Plts\<50x109/L)
- Evidence of serious active infection requiring antibiotic therapy.
- Evidence of active disease requiring steroid or cytotoxic therapy.
- Pregnancy.
- Contraindication for donation due to donor disease: HIV-1; HBsAg positivity.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00855452
Start Date
January 1 2009
End Date
May 1 2014
Last Update
June 11 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hadassah University Hospital
Jerusalem, Israel, 91120