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

Tumors Clinical Trial

Official title:

Tumor-Selective and Systemic Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With rIL-2 and Non-Myeloablative Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00149006
• Other study ID #: 271296-HMO-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: March 13, 2007
• Start date: December 1996

Study information

• Verified date: September 2005
• Source: Hadassah Medical Organization
• Contact: Shimon Slavin, MD
• Phone: +972-2-6776561
• Email: slavin[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Tumors

Intervention

Procedure:
• Cell therapy

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study the feasibility, toxicity, and response to treatment with allogeneic mini-transplant using sibling donors in patients with metastatic cancer