Colorectal CancerPhase 1/2NCT00722228
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors
A Phase 1/2 study testing Autologous or Allogeneic tumor cells in people with Colorectal Cancer and Ovarian Cancer, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Ovarian Cancer, Gastric Cancer
- What is being tested?
- Autologous or Allogeneic tumor cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Below 18 years of age
- Women who are pregnant
- Life expectancy of less than three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Tamar Peretz, MD
About this study
This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer patients.
- Conditions
- Colorectal Cancer, Ovarian Cancer, Gastric Cancer, Breast Cancer, Lung Cancer, Kidney Cancer
- Being tested
- Autologous or Allogeneic tumor cells
- Medical subject headings
- Colorectal Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Breast Neoplasms, Lung Neoplasms, Kidney Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous or Allogeneic tumor cellsBiological
Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| Autologous or Allogeneic tumor cells | Experimental | Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously. Receives: Biological: Autologous or Allogeneic tumor cells |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722228
- Sponsor's protocol ID
- 0359-08-HMO-CTIL
- Status last verified
- Mar 2025
- First submitted
- 23 Jul 2008
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors
- ClinicalTrials.gov ID
- NCT00722228
- Acronym / sponsor ID
- 0359-08-HMO-CTIL
- Conditions
- Colorectal Cancer, Ovarian Cancer, Gastric Cancer, Breast Cancer, Lung Cancer, Kidney Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Mar 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous or Allogeneic tumor cells | Experimental | Biological: Autologous or Allogeneic tumor cellsIntervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Below 18 years of age
- Women who are pregnant
- Life expectancy of less than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous or Allogeneic tumor cellsFive vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells. | Biological | Autologous or Allogeneic tumor cells |
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous or Allogeneic tumor cells in people with Colorectal Cancer and Ovarian Cancer, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hani Steinberg, R.N. B.A. (: 00 972 50 7874292, hanis@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.