Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors (rIL-2(LAK))

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00855452
First received: February 19, 2009
Last updated: March 3, 2009
Last verified: October 2008
  Purpose

The present protocol is a phase 2 study 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 metastatic solid tumors resistant to conventional treatment modalities. Patients will be eligible to participate in a treatment program based on systemic administration of mismatched lymphocytes activated in vitro with rIL-2 (LAK) followed by rIL-2 inoculation in vivo. This treatment is aiming to induce an anti-tumor effect mediated by the efficient killing activity of the rIL-2 activated cells. Prior to cell infusion patients will receive the conditioning treatment with low dose Cyclophosphamide (Cyc) or Fludarabine with 2 injections of low dose alpha interferon. Cell therapy will be combined with specific anti-tumor monoclonal antibodies if available for the specific disease. Further activation of the anti-tumor activity of alloreactive donor T cells and natural killer (NK) cells will be accomplished by in vivo inoculation of rIL-2, aiming for enhancing the anti-cancer potential of donor-derived effectors cells. Patients will receive one - three cycles of cell therapy, as long as there are no signs of Graft- versus - Host - disease (GVHD) and the malignant disease is controlled.


Condition Intervention Phase
Metastatic Breast Cancer
Malignant Melanoma
Renal Cell Cancer
Gastrointestinal Cancer
Procedure: one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect (GVT) in Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • CR:disappearance of disease.PR:<50% decrease in the total tumor load of the lesions SD:<50% reduction and 25% increase in the sum of the products of the longest perpendicular diameters of the measured lesions.PD:>25% increase in the size of lesion. [ Time Frame: on day +7 day +17, day +28 post cell therapy. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically
    Patients will be eligible to participate in a treatment program based on systemic administration of mismatched lymphocytes activated in vitro with rIL-2(LAK) followed by rIL-2 inoculation in vivo
  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Consenting patients (age 12-70) will be eligible for participation in the study involving anti-tumor immunotherapy provided the following criteria are met:

  1. Evidence of cancer not expected to be cured with conventional modalities:

    Pediatric patients: Chemotherapy-resistant neuroblastoma stage 4 & sarcomas. Adult patients: Metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovary cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, metastatic prostate cancer.

  2. Patients with measurable disease evaluable for response with anticipated life expectancy >3 months.
  3. Patients must be >2 weeks off anti-cancer or potentially immunosuppressive treatment.
  4. Adequate ambulatory performance status (Karnofsky >80%; ECOG 0-1) to enable outpatient treatment (see Appendix 1).
  5. Compliant and cooperative patients anticipated to be evaluable for response according to investigator's assessment.
  6. HLA-noncompatible (partial matched or mismatched) donor available.

Exclusion Criteria:

Patients will be excluded from participation in the study if any of the following criteria are met:

  1. Any of the above criteria are not met.
  2. Patients with a significant history or current evidence of potentially severe cardiovascular disease.
  3. Hepatic and/or renal failure.
  4. Abnormal PT and PTT.
  5. Patients with abnormal hemogram (PMN<1.0x109/L; HB<10; Plts<50x109/L)
  6. Evidence of serious active infection requiring antibiotic therapy.
  7. Evidence of active disease requiring steroid or cytotoxic therapy.
  8. Pregnancy.
  9. Contraindication for donation due to donor disease: HIV-1; HBsAg positivity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855452

Contacts
Contact: Preuven Or, Prof., M.D. 972-(2)-6776561 reuvenor@hadassah.org.il
Contact: Liliane Dray, RN 972-(50)-8573250 Lilane@hadassah.org.il

Locations
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Reuven Or, Prof., M.D.    972-(2)-6776551    reuvenor@hadassah.org.il   
Contact: Liliane Dray, RN    972-(50)-8573250    Lilane@hadassah.org.il   
Principal Investigator: Reuven Or, Prof., M.D.         
Sub-Investigator: Igor B. Resnick, Prof., M.D.,Ph.D., D. Sci         
Sub-Investigator: Michael Y Shapira, M.D.         
Sub-Investigator: Bejumin Gesundheit, M.D.         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Reuven Or, Prof., M.D. Hadassah University Hospital
  More Information

No publications provided

Responsible Party: Prof. Reuven Or, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00855452     History of Changes
Other Study ID Numbers: 0457-08-HMO-CTIL
Study First Received: February 19, 2009
Last Updated: March 3, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
GVL
rIL-2(LAK)
GVHD
MST
alloCT
alloBMT

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Breast Neoplasms
Melanoma
Gastrointestinal Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 01, 2014