Metastatic Solid TumorMiniSolidNCT00997529
Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors
A study testing nonmyeloablative stem cell transplant in people with Metastatic Solid Tumor, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
A major focus of recent research has been the development of effective ways of sensitizing the patient's immune system to recognize the cancer as foreign. Allogeneic stem cell transplantation represents a novel way of potentially achieving this goal. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- nonmyeloablative stem cell transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jun 2010
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- Candidates for this trial will be patients with metastatic solid tumors for whom no standard therapy exists or who have evidence of measurable disease that is clearly progressing following standard biologic therapy or chemotherapy for metastatic disease.
- Patients must have a healthy family member who is HLA-identical to the recipient and who is willing and able to receive a course of G-CSF and undergo 2- 4 daily leukaphereses.
- Each patient must be willing to participate as a research subject and must sign an informed consent form.
- Patients must be ambulatory with good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).
- Patients must have adequate organ function as defined by:
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- WBC > 3000/mm3, plt > 100,000/mm3, and hemoglobin > 10gm/100ml
- Serum creatinine < 1.8mg/dl or Cr clearance > 60cc/min.
- Total bilirubin < 1.5mg/dl
- No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias
- LVEF ≥40% by echocardiogram or MUGA scan (Patients whose LVEF is between 40% and 50% will have their cyclophosphamide dose reduced by 25% to 45 mg/kg/d for 2 days (total dose of 90 mg/kg).)
- FEV1 > 2.0 liters or > 75% of predicted for height and age.
- Patients must not be on systemic corticosteroids for intercurrent illness.
- Patients must be between 18 and 60 years of age. Patients over 60 will be accrued on an individual basis with approval of BMT service attendings.
- Women of childbearing potential must have a negative pregnancy test and not become pregnant while on treatment.
- Donors:
- Absence of hematologic or marrow function-related diseases that interfere with the collection of sufficient numbers of normal progenitor cells.
- Absence of any medical condition that would pose a serious health risk to a patient undergoing peripheral blood stem cell harvest.
- Negative HIV, HTLV-1, and hepatitis C serologies.
- Negative for hepatitis B surface antigen (NOTE: Donors who are hepatitis B surface antibody and/or core antibody positive BUT hepatitis B surface antigen negative will be considered for transplant.)
- The donor must be a blood relation. Any healthy family member will be considered for marrow donation. Selection of a donor will be based on typing of HLA-A, B, DR loci to be carried out on the recipient, siblings, parents and possibly other family members such as aunts, uncles and cousins. A prospective related donor must be HLA identical to the patient.
Who cannot join
- Patients:
- Patients with brain metastases, leptomeningeal disease or seizure. (NOTE: Patients with a history of brain metastases must be 6 months from definitive therapy (i.e. surgery or radiation) and have no evidence of disease or edema on brain CT scan or MRI.)
- Female patients who are pregnant or breast-feeding
- ECOG performance status >1. (Karnofsky PS <80%) (See Appendix 1.)
- Left ventricular ejection fraction of < 40%.
- Active viral (e.g. chronic active hepatitis), bacterial or fungal infection.
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- Patients seropositive for HIV, HTLV -1,
- Patients not providing informed consent.
- Patients with known hypersensitivity to E. coli-derived products.
- Donors:
- A positive HIV or HTLV-1 test or evidence of active/persistent viral hepatitis infection will exclude the donor from participation in this study. Donors who are HIV or HTLV-1 positive are ineligible because of the risk of transmission of virus during peripheral blood stem cell transplantation. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Known hypersensitivity to E. coli-derived products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: Nonmyeloablative Allogeneic Stem Cell Transplantation for the Treatment of Solid
A major focus of recent research has been the development of effective ways of sensitizing the patient's immune system to recognize the cancer as foreign. Allogeneic stem cell transplantation represents a novel way of potentially achieving this goal. There is recent evidence that non-myeloablative allogeneic stem cell transplantation provides effective therapy for patients with metastatic renal cell carcinoma. Based on the preliminary reports from other investigators treating patient with breast and ovarian cancer, the investigators of this study would propose treating an expanded cohort of patients with any metastatic solid tumor.
The principal endpoints of the trial will include incidence of durable engraftment, quality of hematopoietic and immune reconstitution, extent of donor chimerism, incidence and severity of acute and chronic graft versus host disease (GVHD), and incidence of long-term disease free survival (DFS). The investigators will evaluate the tumor response of patients with stable or progressive disease post-transplant to donor lymphocyte infusions (DLI). The investigators will also study the effects of DLI on T-cell immunity in the recipients.
Read the detailed description
The trial is a pilot study in which patients with metastatic solid tumors will undergo non-myeloablative allogeneic hematopoietic stem cell transplantation. Patients whose immunosuppressive therapy has been tapered off, are without GVHD, and have evidence of residual or progressive disease will undergo DLI.
In recent years there have been attempts to harness the graft-versus-tumor effect of allogeneic bone marrow transplant to treat patients with metastatic solid tumors. Researchers at the NIH recently reported on 19 patients with refractory metastatic renal-cell carcinoma who had suitable donors and received a preparative regimen of cyclophosphamide and fludarabine followed by an infusion of a peripheral-blood stem-cell allograft from an HLA-identical sibling or a sibling with a mismatch of a single HLA antigen.49 They note that at the time of the last follow-up, 9 of the 19 patients were alive 287 to 831 days after transplantation (median follow-up: 402 days). Two had died of transplantation-related causes and 8 of progressive disease. In 10 patients (53%) metastatic disease regressed: 3 had a complete response, and 7 had a partial response. The patients who had a complete response remained in remission 27, 25, and 16 months after transplantation. Regression of metastases was delayed, occurring a median of 129 days after transplantation, and often followed the withdrawal of cyclosporine and the establishment of complete donor T-cell chimerism. They concluded that these results were consistent with a graft-versus-tumor effect and that non-myeloablative allogeneic stem cell transplantation can induce sustained regression of metastatic RCCA in patients who have had no response to conventional immunotherapy.
- Conditions
- Metastatic Solid Tumor
- Being tested
- nonmyeloablative stem cell transplant
- Keywords
- Stem cell transplant, Non-myeloablative, Metastatic Solid Tumor, Donor Leukocyte Infusion
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonmyeloablative stem cell transplantDrug
Conditioning includes cytoxan 60mg/kg/d on Days 6 \& 5, total dose 120mg/kg, Fludarabine 25mg/m2/d on days -5 to -1, total dose 125mg/m2. Patients with decreased cardiac or liver function pre-transplant will have their dose of cytoxan reduced by 25% - 45 mg/kg/d for 2 days or total dose of 90mg/kg. Patients will receive G-CSF (5ug/kg) to foster engraftment. PBSC progenitors will be mobilized from donor with G-CSF 5ug/kg 2x daily starting 4 days prior to stem cell collection until a target of 5-10 x106 CD34+ cells/kg is reached. Peripheral blood progenitors will be isolated from leukaphereses obtained on Days 5 \& 6 with additional collections dependent on cell yields. Peripheral blood from donors will be given to patients 1 day after cytoreduction \& immunosuppression. Immunosuppression will be tapered Day +60 if no signs of GVHD. Patients with residual non-regressing disease or mixed chimerism after day 100, who are off immunosuppression \& do not have signs of GVHD, will receive a DLI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: nonmyeloablative stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the percent 100-day survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic stem cell transplantation (SCT).
Measured: 100 days
To determine the incidence of treatment-related toxicity and acute and chronic graft versus host disease.
Measured: 100 days
Secondary outcomes (2)
To determine the overall survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic SCT.
Measured: 2 years
To evaluate the tumor response in patients with metastatic solid tumors undergoing non-myeloablative allogeneic SCT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startNov 2000
- Primary completionNov 2007
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, David McDermott, Beth Israel Deaconess Medical Center
- Investigators
- David F McDermott, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997529
- Sponsor's protocol ID
- E-00-0154-FB/2001-P-000092/8
- Acronym
- MiniSolid
- Status last verified
- Jul 2016
- First submitted
- 5 May 2008
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonmyeloablative Allogeneic Stem Cell Transplantation for the Treatment of Solid
- ClinicalTrials.gov ID
- NCT00997529
- Acronym / sponsor ID
- MiniSolid / E-00-0154-FB/2001-P-000092/8
- Conditions
- Metastatic Solid Tumor
- Keywords
- Stem cell transplant, Non-myeloablative, Metastatic Solid Tumor, Donor Leukocyte Infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Nov 2000
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Oct 2009 (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.
A major focus of recent research has been the development of effective ways of sensitizing the patient's immune system to recognize the cancer as foreign. Allogeneic stem cell transplantation represents a novel way of potentially achieving this goal. There is recent evidence that non-myeloablative allogeneic stem cell transplantation provides effective therapy for patients with metastatic renal cell carcinoma. Based on the preliminary reports from other investigators treating patient with breast and ovarian cancer, the investigators of this study would propose treating an expanded cohort of patients with any metastatic solid tumor.
The principal endpoints of the trial will include incidence of durable engraftment, quality of hematopoietic and immune reconstitution, extent of donor chimerism, incidence and severity of acute and chronic graft versus host disease (GVHD), and incidence of long-term disease free survival (DFS). The investigators will evaluate the tumor response of patients with stable or progressive disease post-transplant to donor lymphocyte infusions (DLI). The investigators will also study the effects of DLI on T-cell immunity in the recipients.
Detailed description
The trial is a pilot study in which patients with metastatic solid tumors will undergo non-myeloablative allogeneic hematopoietic stem cell transplantation. Patients whose immunosuppressive therapy has been tapered off, are without GVHD, and have evidence of residual or progressive disease will undergo DLI.
In recent years there have been attempts to harness the graft-versus-tumor effect of allogeneic bone marrow transplant to treat patients with metastatic solid tumors. Researchers at the NIH recently reported on 19 patients with refractory metastatic renal-cell carcinoma who had suitable donors and received a preparative regimen of cyclophosphamide and fludarabine followed by an infusion of a peripheral-blood stem-cell allograft from an HLA-identical sibling or a sibling with a mismatch of a single HLA antigen.49 They note that at the time of the last follow-up, 9 of the 19 patients were alive 287 to 831 days after transplantation (median follow-up: 402 days). Two had died of transplantation-related causes and 8 of progressive disease. In 10 patients (53%) metastatic disease regressed: 3 had a complete response, and 7 had a partial response. The patients who had a complete response remained in remission 27, 25, and 16 months after transplantation. Regression of metastases was delayed, occurring a median of 129 days after transplantation, and often followed the withdrawal of cyclosporine and the establishment of complete donor T-cell chimerism. They concluded that these results were consistent with a graft-versus-tumor effect and that non-myeloablative allogeneic stem cell transplantation can induce sustained regression of metastatic RCCA in patients who have had no response to conventional immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: nonmyeloablative stem cell transplant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Candidates for this trial will be patients with metastatic solid tumors for whom no standard therapy exists or who have evidence of measurable disease that is clearly progressing following standard biologic therapy or chemotherapy for metastatic disease.
- Patients must have a healthy family member who is HLA-identical to the recipient and who is willing and able to receive a course of G-CSF and undergo 2- 4 daily leukaphereses.
- Each patient must be willing to participate as a research subject and must sign an informed consent form.
- Patients must be ambulatory with good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).
- Patients must have adequate organ function as defined by:
Key exclusion criteria (11 listed)
- Patients with brain metastases, leptomeningeal disease or seizure. (NOTE: Patients with a history of brain metastases must be 6 months from definitive therapy (i.e. surgery or radiation) and have no evidence of disease or edema on brain CT scan or MRI.)
- Female patients who are pregnant or breast-feeding
- ECOG performance status >1. (Karnofsky PS <80%) (See Appendix 1.)
- Left ventricular ejection fraction of < 40%.
- Active viral (e.g. chronic active hepatitis), bacterial or fungal infection.
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 |
|---|---|---|
| nonmyeloablative stem cell transplantConditioning includes cytoxan 60mg/kg/d on Days 6 \& 5, total dose 120mg/kg, Fludarabine 25mg/m2/d on days -5 to -1, total dose 125mg/m2. Patients with decreased cardiac or liver function pre-transplant will have their dose of cytoxan reduced by 25% - 45 mg/kg/d for 2 days or total dose of 90mg/kg. Patients will receive G-CSF (5ug/kg) to foster engraftment. PBSC progenitors will be mobilized from donor with G-CSF 5ug/kg 2x daily starting 4 days prior to stem cell collection until a target of 5-10 x106 CD34+ cells/kg is reached. Peripheral blood progenitors will be isolated from leukaphereses obtained on Days 5 \& 6 with additional collections dependent on cell yields. Peripheral blood from donors will be given to patients 1 day after cytoreduction \& immunosuppression. Immunosuppression will be tapered Day +60 if no signs of GVHD. Patients with residual non-regressing disease or mixed chimerism after day 100, who are off immunosuppression \& do not have signs of GVHD, will receive a DLI | Drug | 1 |
Primary outcome
To determine the percent 100-day survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic stem cell transplantation (SCT).
Time frame: 100 days
To determine the incidence of treatment-related toxicity and acute and chronic graft versus host disease.
Time frame: 100 days
2 secondary outcomes
To determine the overall survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic SCT.
Time frame: 2 years
To evaluate the tumor response in patients with metastatic solid tumors undergoing non-myeloablative allogeneic SCT.
Time frame: 2 years
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 18 Jul 2016.
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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.
David F McDermott, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nonmyeloablative stem cell transplant in people with Metastatic Solid Tumor, run by Beth Israel Deaconess Medical Center 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?
The sponsor lists 21 inclusion and 11 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 18 Jul 2016. 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.
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.
What does the primary outcome measure?
To determine the percent 100-day survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic stem cell transplantation (SCT). (time frame: 100 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Jul 2016.