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rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect (GVT) in Metastatic Solid Tumors

Phase 2
12 Years
70 Years
Open (Enrolling)
Metastatic Breast Cancer, Malignant Melanoma, Renal Cell Cancer, Gastrointestinal Cancer

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Trial Information

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR:disappearance of disease.PR:<50% decrease in the total tumor load of the lesions SD:<50% reduction and 25% increase in the sum of the products of the longest perpendicular diameters of the measured lesions.PD:>25% increase in the size of lesion.

Outcome Time Frame:

on day +7 day +17, day +28 post cell therapy.

Safety Issue:


Principal Investigator

Reuven Or, Prof., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah University Hospital


Israel: Ministry of Health

Study ID:




Start Date:

January 2009

Completion Date:

January 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Malignant Melanoma
  • Renal Cell Cancer
  • Gastrointestinal Cancer
  • GVL
  • rIL-2(LAK)
  • GVHD
  • MST
  • alloCT
  • alloBMT
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Melanoma
  • Gastrointestinal Neoplasms