Breast CancerPhase 1NCT00301730
Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
A Phase 1 study testing aldesleukin, therapeutic tumor infiltrating lymphocytes and trastuzumab in people with Breast Cancer and Metastatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Metastatic Cancer
- What is being tested?
- aldesleukin, therapeutic tumor infiltrating lymphocytes and trastuzumab
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of stage IIB HER2/neu-expressing breast cancer 6½ years ago
- Received a T-cell-depleted allogeneic stem cell transplantation (SCT) from a 6/6 HLA-matched sibling donor for refractory metastatic breast cancer
- Developed pulmonary metastases during adjuvant chemotherapy following modified radical mastectomy
- Pulmonary metastases progressed after prior allogeneic SCT
- Responded in an objective and measurable manner to prior allogeneic lymphocyte infusion, post-transplantation chemotherapy, and trastuzumab (Herceptin®)
- Disease limited to the thoracic cavity
- Operable tumor with at least 1 cm of surgically accessible lesion
- Preoperative risk assessment indicating ≤ 5% risk of mortality and < 15% risk of significant morbidity for pulmonary metastasectomy
- Enrolled on protocol CC# 00-C-0119
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy > 6 months
- Negative pregnancy test
- Adequate pulmonary reserve
- Prior graft-versus-host disease (GVHD) ≤ grade 1
- No concurrent GVHD
- No active infection nonresponsive to antimicrobial therapy
- No active psychiatric disorder that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior systemic immunosuppressive therapy
- At least 2 weeks since prior cytotoxic therapy and immunotherapy (e.g. trastuzumab [Herceptin®])
- No concurrent immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation
RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for breast cancer that has spread to the lung.
Read the detailed description
OBJECTIVES:
Primary
- Determine the antitumor response in a patient with persistent metastatic breast cancer after prior allogeneic hematopoietic stem cell transplantation (SCT) treated with tumor-derived, ex vivo expanded and costimulated T-lymphocytes.
Secondary
- Evaluate the immune function of tumor-derived T-lymphocytes and the biology of residual tumor cells present after allogeneic hematopoietic SCT.
OUTLINE: This is a pilot study.
The patient undergoes surgical resection of the accessible lesions from which T cells are isolated, costimulated, and expanded ex vivo to produce the tumor-derived T-lymphocytes (TDTL). Beginning at least 2 weeks after surgery, the patient receives TDTL IV every 4 weeks for up to 5 doses in the presence of disease progression (DP) AND in the absence of ≥ grade 2 graft-versus-host disease. The patient is assessed 4 weeks after every dose.
In case of stable disease, partial response, or complete response, the patient is followed without intervention until DP.
In case of DP after dose 1 or 2 of the TDTL, the patient receives dose 2 or 3 of the TDTL. In case of DP after dose 3 of the TDTL, the patient receives low-dose interleukin-2 subcutaneously (SC) daily for 3 days and dose 4 of the TDTL. In case of DP after dose 4 of the TDTL, the patient receives 1 course of chemoimmunotherapy for cytoreduction and immunomodulation comprising paclitaxel IV over 3 hours once and trastuzumab (Herceptin®) IV over 30-90 minutes once weekly for 3 weeks (the patient may receive gemcitabine hydrochloride, vinorelbine ditartrate, docetaxel, or capecitabine in combination with trastuzumab [Herceptin®] as chemoimmunotherapy at the discretion of the principal investigator); interleukin-2 SC daily for 3 days; and dose 5 of the TDTL. In case of DP after dose 5 of the TDTL, the patient may receive cytotoxic chemotherapy and/or FDA-approved biologic therapy and/or immunotherapy with donor lymphocyte infusions from the same donor used for the prior allogeneic stem cell transplantation.
The patient may undergo core biopsy of the left mediastinal nodule in case of tumor regression of the indexing lesion at anytime OR after receiving dose 5 of the TDTL.
After completion of study treatment, the patient is followed periodically for 5 years.
PROJECTED ACCRUAL: One patient will be accrued for this study.
- Conditions
- Breast Cancer, Metastatic Cancer
- Being tested
- aldesleukin, therapeutic tumor infiltrating lymphocytes, trastuzumab, paclitaxel, conventional surgery
- Keywords
- lung metastases, stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
therapeutic tumor infiltrating lymphocytesBiological
trastuzumabBiological
paclitaxelDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startOct 2005
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 National Cancer Institute (NCI)The 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
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael R. Bishop, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301730
- Sponsor's protocol ID
- CDR0000455626
- Other IDs
- NCI-05-C-9980, NCI-SE-05-03
- Status last verified
- Apr 2006
- First submitted
- 9 Mar 2006
- Last updated
- 28 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00301730
- Acronym / sponsor ID
- CDR0000455626
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- lung metastases, stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2005
- First posted
- 13 Mar 2006 (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: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for breast cancer that has spread to the lung.
Detailed description
OBJECTIVES:
Primary
- Determine the antitumor response in a patient with persistent metastatic breast cancer after prior allogeneic hematopoietic stem cell transplantation (SCT) treated with tumor-derived, ex vivo expanded and costimulated T-lymphocytes.
Secondary
- Evaluate the immune function of tumor-derived T-lymphocytes and the biology of residual tumor cells present after allogeneic hematopoietic SCT.
OUTLINE: This is a pilot study.
The patient undergoes surgical resection of the accessible lesions from which T cells are isolated, costimulated, and expanded ex vivo to produce the tumor-derived T-lymphocytes (TDTL). Beginning at least 2 weeks after surgery, the patient receives TDTL IV every 4 weeks for up to 5 doses in the presence of disease progression (DP) AND in the absence of ≥ grade 2 graft-versus-host disease. The patient is assessed 4 weeks after every dose.
In case of stable disease, partial response, or complete response, the patient is followed without intervention until DP.
In case of DP after dose 1 or 2 of the TDTL, the patient receives dose 2 or 3 of the TDTL. In case of DP after dose 3 of the TDTL, the patient receives low-dose interleukin-2 subcutaneously (SC) daily for 3 days and dose 4 of the TDTL. In case of DP after dose 4 of the TDTL, the patient receives 1 course of chemoimmunotherapy for cytoreduction and immunomodulation comprising paclitaxel IV over 3 hours once and trastuzumab (Herceptin®) IV over 30-90 minutes once weekly for 3 weeks (the patient may receive gemcitabine hydrochloride, vinorelbine ditartrate, docetaxel, or capecitabine in combination with trastuzumab [Herceptin®] as chemoimmunotherapy at the discretion of the principal investigator); interleukin-2 SC daily for 3 days; and dose 5 of the TDTL. In case of DP after dose 5 of the TDTL, the patient may receive cytotoxic chemotherapy and/or FDA-approved biologic therapy and/or immunotherapy with donor lymphocyte infusions from the same donor used for the prior allogeneic stem cell transplantation.
The patient may undergo core biopsy of the left mediastinal nodule in case of tumor regression of the indexing lesion at anytime OR after receiving dose 5 of the TDTL.
After completion of study treatment, the patient is followed periodically for 5 years.
PROJECTED ACCRUAL: One patient will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 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 |
|---|---|---|
| aldesleukin | Biological | – |
| therapeutic tumor infiltrating lymphocytes | Biological | – |
| trastuzumab | Biological | – |
| paclitaxel | Drug | – |
| conventional surgery | Procedure or surgery | – |
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 28 Apr 2015.
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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.
Michael R. Bishop, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aldesleukin, therapeutic tumor infiltrating lymphocytes and trastuzumab in people with Breast Cancer and Metastatic Cancer, run by National Cancer Institute (NCI) at 1 site 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?
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 28 Apr 2015. 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 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 28 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.