Personalized (autologous) and donor (allogeneic) whole-cell vaccine for metastatic tumors
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hadassah Medical Organization Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT00722228 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jerusalem
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.