Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With Recombinant Interleukin-2 (rIL-2) for Metastatic Solid Tumors

NCT ID: NCT00149006

Last Updated: 2007-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-12-31

Brief Summary

The present protocol is designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors similarly to the well established graft versus leukemia (GVL) effects in patients with hematologic malignancies.

Patients with metastatic solid tumors resistant to conventional modalities will be eligible to participate in a treatment program based on the administration of non-myeloablative immunotherapy (i.e. fludarabine, Cytoxan) followed by interferon injections; subsequently the patients will be treated with mismatched alloreactive donor lymphocytes activated in vitro and in vivo with rIL-2. The aim of this study is based on the recognition of foreign tumor cell surface alloantigens.

Conditions

Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Cell therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Shimon Slavin, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Reuven Or, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shimon Slavin, MD

Role: CONTACT

slavin@cc.huji.ac.il

+972-2-6776561

Facility Contacts

Shimon Slavin, MD

Role: primary

slavin@hadassah.org.il

+972-2-6776561

Other Identifiers

271296-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id