Metastatic Solid Tumor Clinical Trial
— MiniSolidOfficial 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.
Status | Completed |
Enrollment | 14 |
Est. completion date | June 2010 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria 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: 1. WBC > 3000/mm3, plt > 100,000/mm3, and hemoglobin > 10gm/100ml 2. Serum creatinine < 1.8mg/dl or Cr clearance > 60cc/min. 3. Total bilirubin < 1.5mg/dl 4. No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias 5. 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).) 6. 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. Exclusion Criteria: 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. - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the percent 100-day survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic stem cell transplantation (SCT). | 100 days | Yes | |
Primary | To determine the incidence of treatment-related toxicity and acute and chronic graft versus host disease. | 100 days | Yes | |
Secondary | To determine the overall survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic SCT. | 2 years | Yes | |
Secondary | To evaluate the tumor response in patients with metastatic solid tumors undergoing non-myeloablative allogeneic SCT. | 2 years | Yes |
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