Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation
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
- Adequate ambulatory performance status (Karnofsky > 80%; ECOG 0-1) to enable
- 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.
- Patients with bulky disease or patients with brain metastases resistant to
- 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.
- Contraindication for donation due to donor disease: HIV-1; hepatitis B surface
antigen (HBsAg) positivity.