Status:
UNKNOWN
Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With Recombinant Interleukin-2 (rIL-2) for Metastatic Solid Tumors
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The present protocol is designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors similarly to the well established graft versus leukemia (...
Eligibility Criteria
Inclusion
- Consenting patients (age \< 70) will be eligible for participation in the study involving selective 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 and sarcomas. Adult patients: Metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovarian cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, and metastatic prostate cancer.
- Patients with measurable disease evaluable for response with anticipated life expectancy \> 3 months.
- Patients must be \> 2 weeks off of anti-cancer or potentially immunosuppressive treatment.
- Adequate ambulatory performance status (Karnofsky \> 80%; ECOG 0-1) to enable outpatient treatment.
- Compliant and cooperative patients anticipated to be evaluable for response according to the investigator's assessment.
- HLA-compatible (fully matched or single locus mismatched) donor available for allogeneic stem cell transplantation.
Exclusion
- Patients with bulky disease or patients with brain metastases resistant to chemo-radiotherapy.
- Patients with a significant history or current evidence of potentially severe cardiovascular or lung disease, or other disease or clinical condition that may not permit accomplishing the planned treatment or drawing conclusions.
- Hepatic and/or renal failure.
- Evidence of serious active infection requiring antibiotic therapy.
- Pregnancy.
- Contraindication for donation due to donor disease: HIV-1; hepatitis B surface antigen (HBsAg) positivity.
Key Trial Info
Start Date :
December 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00149006
Start Date
December 1 1996
Last Update
March 14 2007
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120