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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149006
Recruitment Status : Unknown
Verified September 2005 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : September 8, 2005
Last Update Posted : March 14, 2007
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Tumors Procedure: Cell therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation
Study Start Date : December 1996

Primary Outcome Measures :
  1. 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 :
  1. Study the feasibility, toxicity, and response to treatment with allogeneic mini-transplant using sibling donors in patients with metastatic cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149006

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Contact: Shimon Slavin, MD +972-2-6776561

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Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Shimon Slavin, MD    +972-2-6776561   
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Study Director: Reuven Or, MD Hadassah Medical Organization

Layout table for additonal information Identifier: NCT00149006     History of Changes
Other Study ID Numbers: 271296-HMO-CTIL
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 14, 2007
Last Verified: September 2005
Keywords provided by Hadassah Medical Organization:
Metastatic solid tumor
Mismatch allogeneic cell mediated immunotherapy
Additional relevant MeSH terms:
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