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Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Tumors

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Trial Information

Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation


Inclusion Criteria:



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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Study the feasibility, toxicity, and response rate of allogeneic cell therapy induced by selective intra-lesional and systemic administration of mismatched alloreactive lymphocytes in patients with metastatic cancer

Principal Investigator

Shimon Slavin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

271296-HMO-CTIL

NCT ID:

NCT00149006

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Tumors
  • Metastatic solid tumor
  • Mismatch allogeneic cell mediated immunotherapy

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