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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149006
First Posted: September 8, 2005
Last Update Posted: July 25, 2007
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.
Information provided by:
Hadassah Medical Organization
  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 2

Study Type: Interventional
Study Design: 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00149006     History of Changes
Other Study ID Numbers: 271296-HMO-CTIL
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: July 25, 2007
Last Verified: September 2005

Keywords provided by Hadassah Medical Organization:
Metastatic solid tumor
Mismatch allogeneic cell mediated immunotherapy