rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect (GVT) in Metastatic Solid Tumors
Consenting patients (age 12-70) will be eligible for participation in the study involving
anti-tumor immunotherapy provided the following criteria are met:
1. 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.
2. Patients with measurable disease evaluable for response with anticipated life
expectancy >3 months.
3. Patients must be >2 weeks off anti-cancer or potentially immunosuppressive treatment.
4. Adequate ambulatory performance status (Karnofsky >80%; ECOG 0-1) to enable
outpatient treatment (see Appendix 1).
5. Compliant and cooperative patients anticipated to be evaluable for response according
to investigator's assessment.
6. HLA-noncompatible (partial matched or mismatched) donor available.
Patients will be excluded from participation in the study if any of the following criteria
1. Any of the above criteria are not met.
2. Patients with a significant history or current evidence of potentially severe
3. Hepatic and/or renal failure.
4. Abnormal PT and PTT.
5. Patients with abnormal hemogram (PMN<1.0x109/L; HB<10; Plts<50x109/L)
6. Evidence of serious active infection requiring antibiotic therapy.
7. Evidence of active disease requiring steroid or cytotoxic therapy.
9. Contraindication for donation due to donor disease: HIV-1; HBsAg positivity.