Breast CancerPhase 3NCT00002455
Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
A Phase 3 study testing Corynebacterium granulosum P40 and adjuvant therapy in people with Breast Cancer and Colorectal Cancer, run by Centro Oncologico de Excelencia at 1 site in Argentina.
Trial summary
RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Melanoma (Skin)
- What is being tested?
- Corynebacterium granulosum P40 and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteArgentina
- Study dates
- Apr 1971to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 20 to 80
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Centro Oncologico de Excelencia
Manuel B. Gonnet, Buenos Aires, 1987 MB
About this study
Official title: Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.
PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.
Read the detailed description
OBJECTIVES:
- Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
- Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.
Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.
Patients are followed for survival.
PROJECTED ACCRUAL: Not specified
- Conditions
- Breast Cancer, Colorectal Cancer, Melanoma (Skin)
- Being tested
- Corynebacterium granulosum P40, adjuvant therapy
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, recurrent colon cancer, stage I melanoma, stage II melanoma, stage III melanoma, recurrent melanoma
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Melanoma, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corynebacterium granulosum P40Biological
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Response to study parameters
Survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 1971
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Centro Oncologico de Excelencia
- Sponsor type
- University, hospital or other
- Investigators
- Hugo Omar De Carli, MD, Study chair, Centro Oncologico de Excelencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002455
- Sponsor's protocol ID
- ARG-CO/BR-1
- Other IDs
- CDR0000072435
- Status last verified
- Nov 1998
- First submitted
- 1 Nov 1999
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
De Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
- ClinicalTrials.gov ID
- NCT00002455
- Acronym / sponsor ID
- ARG-CO/BR-1
- Conditions
- Breast Cancer, Colorectal Cancer, Melanoma (Skin)
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, recurrent colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Centro Oncologico de ExcelenciaUniversity, hospital or other
- Study start
- Apr 1971
- First posted
- 27 Jan 2003 (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.
RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.
PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.
Detailed description
OBJECTIVES:
- Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
- Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.
Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.
Patients are followed for survival.
PROJECTED ACCRUAL: Not specified
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Corynebacterium granulosum P40 | Biological | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Recurrence
Response to study parameters
Survival rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- BackgroundDe Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia.
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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. This study is not recruiting at the moment.
Hugo Omar De Carli, MD study chair
Centro Oncologico de Excelencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corynebacterium granulosum P40 and adjuvant therapy in people with Breast Cancer and Colorectal Cancer, run by Centro Oncologico de Excelencia at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. 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 Argentina. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002455, which also lists 1 linked publication.
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 7 Aug 2013.