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

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00149006

Purpose

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.

Condition	Intervention	Phase
Tumors	Procedure: Cell therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Study the feasibility, toxicity, and response to treatment with allogeneic mini-transplant using sibling donors in patients with metastatic cancer

Estimated Enrollment:	100
Study Start Date:	December 1996

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149006

Contacts

Contact: Shimon Slavin, MD

+972-2-6776561

slavin@cc.huji.ac.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel, 91120
Contact: Shimon Slavin, MD +972-2-6776561 slavin@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Shimon Slavin, MD	Hadassah Medical Organization
Study Director:	Reuven Or, MD	Hadassah Medical Organization

More Information

Study ID Numbers:	271296-HMO-CTIL
Study First Received:	September 7, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00149006
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Metastatic solid tumor
Mismatch allogeneic cell mediated immunotherapy

Study placed in the following topic categories:

Interleukin-2

ClinicalTrials.gov processed this record on January 16, 2009