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Status unknownNCT00149006Updated Mar 14, 2007

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

A Phase 2 interventional study of Cell therapy in Tumors, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-03-14.

Sponsored by Hadassah Medical Organization · Phase 2 and Interventional

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tumors

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Keywords

  • Metastatic solid tumor
  • Mismatch allogeneic cell mediated immunotherapy
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • ProcedureCell therapy
06

What researchers measure

Primary outcomes

  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 outcomes

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

07

Study locations

1 of 1 sites recruiting
  • Hadassah Medical Organization
    Jerusalem, 91120, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00149006
Lead sponsor
Hadassah Medical Organization
First posted
Sep 8, 2005
Start date
Dec 1996
Last update
Mar 14, 2007

Study contacts

Shimon Slavin, MD
Contact
slavin@cc.huji.ac.il
+972-2-6776561
Shimon Slavin, MD
principal investigator · Hadassah Medical Organization
Reuven Or, MD
study director · Hadassah Medical Organization
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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