Personalized (autologous) and donor (allogeneic) whole-cell vaccine for metastatic tumors
Official title: Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors
Run by Hadassah Medical Organization · NCT00722228 · Data updated 2026-11-12
This will try a vaccine made from a patient's own or donor tumor cells to stimulate the immune system in adults with metastatic cancers and possibly slow disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jerusalem) |
| Status | Recruiting |
| Started | July 2008 |
| Main results expected | March 2025 |
| Study ends | January 2027 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT00722228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 or older) with metastatic melanoma or epithelial cancers (breast, ovary, colorectal, gastric, lung, or kidney) who have failed at least one chemotherapy regimen and have good performance status (ECOG 0–1) are the intended participants.
✕Probably not a fit
Patients under 18, pregnant women, those with life expectancy under three months, or with significant organ dysfunction are likely excluded or unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Tumor cells are grown in the lab, modified to increase immune stimulation, irradiated to kill them, and then injected back into patients on a schedule of eight doses given every two weeks. Both autologous (patient-derived) and allogeneic (donor-derived) whole-cell preparations are used. The Phase 1/2 protocol enrolls adults with metastatic melanoma or epithelial cancers (colorectal, gastric, ovarian, breast, lung, kidney) who have failed at least one chemotherapy regimen and have ECOG performance status 0–1. The trial focuses on safety, immune responses, and any early signals of clinical benefit, with treatments and follow-up at a single center in Jerusalem.
Why it matters
Potential benefit: If successful, this approach could boost patients' immune responses against tumors and potentially slow cancer progression or prolong survival.
How similar studies have gone: Similar whole-cell tumor vaccines have elicited immune responses in prior studies but have produced mixed clinical results with limited proven survival benefit so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney * Above 18 years of age * Failure of at least one chemotherapy protocol * Clinical performance status of ECOG 0,1 * Absolute neutrophil count greater than 1000/mm3 * Serum ALT/AST less than three times the upper limit of normal * Serum creatinine less than or equal to 1.6 mg/dl. * Must be able to understand and sign the Informed Consent document Exclusion Criteria: * Below 18 years of age * Women who are pregnant * Life expectancy of less than three months
Where it's running
-
Hadassah Medical Organization
Jerusalem, Israel Recruiting
Study contacts
- Study coordinator: Hani Steinberg, R.N. B.A.
- Email: hanis@hadassah.org.il
- Phone: : 00 972 50 7874292
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.