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

Primary Purpose

Metastatic Breast Cancer, Malignant Melanoma, Renal Cell Cancer

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring GVL, rIL-2(LAK), GVHD, MST, alloCT, alloBMT

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah University Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2009
Last Updated
June 10, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00855452
Brief Title
Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors
Acronym
rIL-2(LAK)
Official Title
rIL-2 Activated Allogeneic Lymphocytes for the Induction of Graft Versus Tumor Effect (GVT) in Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Malignant Melanoma, Renal Cell Cancer, Gastrointestinal Cancer
Keywords
GVL, rIL-2(LAK), GVHD, MST, alloCT, alloBMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically
Intervention Description
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
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. Patients with measurable disease evaluable for response with anticipated life expectancy >3 months. Patients must be >2 weeks off anti-cancer or potentially immunosuppressive treatment. Adequate ambulatory performance status (Karnofsky >80%; ECOG 0-1) to enable outpatient treatment (see Appendix 1). Compliant and cooperative patients anticipated to be evaluable for response according to investigator's assessment. 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: Any of the above criteria are not met. Patients with a significant history or current evidence of potentially severe cardiovascular disease. Hepatic and/or renal failure. Abnormal PT and PTT. Patients with abnormal hemogram (PMN<1.0x109/L; HB<10; Plts<50x109/L) Evidence of serious active infection requiring antibiotic therapy. Evidence of active disease requiring steroid or cytotoxic therapy. Pregnancy. Contraindication for donation due to donor disease: HIV-1; HBsAg positivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reuven Or, Prof., M.D.
Organizational Affiliation
Hadassah University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors

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