rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect (GVT) in Metastatic Solid Tumors
Inclusion Criteria:
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.
Exclusion Criteria:
Patients will be excluded from participation in the study if any of the following criteria
are met:
1. Any of the above criteria are not met.
2. Patients with a significant history or current evidence of potentially severe
cardiovascular disease.
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.
8. Pregnancy.
9. Contraindication for donation due to donor disease: HIV-1; HBsAg positivity.