Breast CancerPhase 1NCT00003761
Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
A Phase 1 study testing rV-DF3/MUC1 in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the safest dose which should be used in the treatment of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- rV-DF3/MUC1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Mar 1999to 19 Oct 2001
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologically confirmed diagnosis of metastatic adenocarcinoma of the breast. Patients may have measurable disease, but it is not required. Patients may have received any number of prior therapies for metastatic disease. Untreated patients are also eligible.
- Age ≥ 18 years
- Patients must have an ECOG = Performance Status of 0-1
- Patients must have a WBC > 2000/mm 3 and a platelet count > 100,000/mm3.
- Patients must have adequate renal function documented by a serum creatinine < 2.0 mg/d1.
- Patients must have adequate liver function demonstrated by a serum bilirubin < 2.0 mg/di, and a SGPT < 4 times the upper limit of normal.
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- ≥3 weeks since chemotherapy (> 6 weeks for nitosoureas or mitomycin C), hormonal therapy or radiation therapy
- Immunologic testing must be at least normal as defined by at least normal delayed type hypersensitivity, at least normal CD4: CD8 ratio (>1), at least normal lymphocyte proliferation testing (to Con A), and at least normal immunoglobulin levels
- Patients must not have evidence of altered immune responsiveness or autoimmune syndromes (scleroderma,systemic lupus erythematosus, etc.). Patients must be HIV negative. This treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity.
- Patients must not have undergone splenectomy.
- Patients with active cases or history of extensive skin disorders (such as extensive psoriasis, burns, impetigo, disseminated zoster) are ineligible.
- Patients must not have any other serious medical condition which in the opinion of the investigator is incompatible with the protocol. Patients with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days.
- Patients must be able to avoid close contact with children < 3 years of age, pregnant women, individuals with eczema or skin conditions and immune suppressed individuals during a period of two weeks after each vaccination.
- Patients must have had prior vaccinia (small pox) exposure.
- Tumor tissue positive for staining with MAbs DF3 and/or DF3-P or elevated serum CA15-3. Note: This can be done on stored slides.
- Patients must not have a history of seizures, encephalitis or multiple sclerosis.
- Patients must not be allergic to eggs.
- Patients must not be pregnant or breast-feeding due to a possible increased risk with exposure to vaccinia virus of both mother and newborn as well as unknown risks to the fetus.
- Signed informed consent.
Who cannot join
- Patients must not have evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.). Patients must be HIV negative This treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity.
- Patients must not have undergone splenectomy
- Patients with active cases or history of extensive skin disorders (such as extensive psoriasis, burns, impetigo, disseminated zoster) are ineligible.
- Patients must not have any other serious medical condition which in the opinion of the investigator is incompatible with the protocol. Patients with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adenocarcinoma of the Breast
This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the safest dose which should be used in the treatment of breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II. Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity, in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with antitumor activity in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the highest dose level to be tested is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2 years.
- Conditions
- Breast Cancer
- Being tested
- rV-DF3/MUC1
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rV-DF3/MUC1Biological
- The starting dose for this Phase I study of rV-DF3/MUC1 will be 4.76 x 106 PFU.
-- Dose escalation will proceed with cohorts of at least 6 patients as follows: Per vaccination
- Level 1 4.76 x 106 PFU
- Level 2 4.76 x 107 PFU
- Level 3 4.76 x 108 PFU
| Study group | Role | What they receive |
|---|---|---|
| rV-DF3/MUC1 | Experimental | * rV-DF3/MUC1 vaccinations will be administered 4 week intervals for a total of 3 doses.
* Participants will be followed weekly until 28 days after the final dose (day 85) then month for 6 months Receives: Biological: rV-DF3/MUC1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2003 (estimated)
- Study start3 Mar 1999
- Primary completion20 Apr 2001
- Study completion19 Oct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Donald W. Kufe, Dana-Farber Cancer Institute
- Investigators
- Donald W. Kufe, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003761
- Sponsor's protocol ID
- 97-050
- Other IDs
- U01CA062490, P30CA006516, NCI-T98-0057
- Status last verified
- Feb 2017
- First submitted
- 1 Nov 1999
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adenocarcinoma of the Breast
- ClinicalTrials.gov ID
- NCT00003761
- Acronym / sponsor ID
- 97-050
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Mar 1999 (actual)
- Primary completion
- 20 Apr 2001 (actual)
- Study completion
- 19 Oct 2001 (actual)
- First posted
- 10 Dec 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.
This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the safest dose which should be used in the treatment of breast cancer.
Detailed description
OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II. Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity, in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with antitumor activity in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the highest dose level to be tested is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rV-DF3/MUC1 | Experimental | Biological: rV-DF3/MUC1* rV-DF3/MUC1 vaccinations will be administered 4 week intervals for a total of 3 doses. * Participants will be followed weekly until 28 days after the final dose (day 85) then month for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with a histologically confirmed diagnosis of metastatic adenocarcinoma of the breast. Patients may have measurable disease, but it is not required. Patients may have received any number of prior therapies for metastatic disease. Untreated patients are also eligible.
- Age ≥ 18 years
- Patients must have an ECOG = Performance Status of 0-1
- Patients must have a WBC > 2000/mm 3 and a platelet count > 100,000/mm3.
- Patients must have adequate renal function documented by a serum creatinine < 2.0 mg/d1.
Key exclusion criteria (4 listed)
- Patients must not have evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.). Patients must be HIV negative This treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity.
- Patients must not have undergone splenectomy
- Patients with active cases or history of extensive skin disorders (such as extensive psoriasis, burns, impetigo, disseminated zoster) are ineligible.
- Patients must not have any other serious medical condition which in the opinion of the investigator is incompatible with the protocol. Patients with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days.
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 |
|---|---|---|
| rV-DF3/MUC1- The starting dose for this Phase I study of rV-DF3/MUC1 will be 4.76 x 106 PFU. -- Dose escalation will proceed with cohorts of at least 6 patients as follows: Per vaccination * Level 1 4.76 x 106 PFU * Level 2 4.76 x 107 PFU * Level 3 4.76 x 108 PFU | Biological | rV-DF3/MUC1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Donald W. Kufe, MD study chair
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rV-DF3/MUC1 in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
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 19 inclusion and 4 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: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 15 Feb 2017.