A Phase 1/2 interventional study of fludarabine phosphate and total-body irradiation in Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 6 sites in United States. Open to participants aged Up to 74 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Treatment
The reason for doing this study is to see if cancer will respond to immune therapy after transplantation of blood stem cells (from the bone marrow) using a new kind of treatment regimen that is less toxic than that previously used for blood stem cell transplants. This type of transplant uses much less chemotherapy and radiation than standard bone marrow transplants. The treatment consists of medications that weaken the immune system so it doesn't reject the donor's marrow cells. Researchers hope that the immune cells from the donor will attack the tumor. This is called a "graft versus tumor" effect and has been seen in other types of cancer. In addition, 65 days or more after the transplant the patient may be eligible for an immune treatment that uses additional immune cells from the donor to increase the effect of the stem cells against the cancer.
PRIMARY OBJECTIVES:
I. To determine whether mixed or full donor hematopoietic chimerism can be safely established using a non-myeloablative conditioning regimen.
II. To determine whether mixed chimerism can be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes (DLI).
III. To evaluate potential efficacy of this approach as a treatment for metastatic renal cancer.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo low-dose total-body irradiation (TBI) on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.
IMMUNOSUPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV once daily (QD) or BID on days -3 to 35 with taper to day 56, and mycophenolate mofetil PO or IV over 2 hours thrice daily (TID) on days 0-40.
DLI: Patients with stable mixed chimerism on day 56 with no evidence of graft-vs-host disease (GVHD) may receive escalating doses of non-mobilized DLI over 30 minutes. Patients may receive up to 4 DLIs at escalating doses if there is disease progression with no evidence of GVHD.
After completion of study treatment, patients are followed up periodically for 5 years.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 11 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
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Exclusion Criteria:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. IMMUNOSUPRESSION: Patients receive cyclosporine PO BID or IV QD or BID on days -3 to 35 with taper to day 56, and mycophenolate mofetil PO or IV over 2 hours TID on days 0-40. DLI: Patients with stable mixed chimerism on day 56 with no evidence of GVHD may receive escalating doses of non-mobilized DLI over 30 minutes. Patients may receive up to 4 DLIs at escalating doses if there is disease progression with no evidence of GVHD.
Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Procedure: peripheral blood stem cell transplantation · Biological: therapeutic allogeneic lymphocytes · Other: laboratory biomarker analysis
Given IV
Also known as: 2-F-ara-AMP, Beneflur, Fludara
Undergo TBI
Also known as: TBI
Undergo nonmyeloablative allogeneic PBSC transplantation
Given PO or IV
Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune
Given PO or IV
Also known as: Cellcept, MMF
Undergo nonmyeloablative allogeneic PBSC transplantation
Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Undergo DLI
Also known as: ALLOLYMPH
Correlative studies
True response rate (complete response [CR] or partial response [PR]) greater than the 15% achievable with standard therapy
If 6 or more out of 25 patients achieve a CR or PR, then there is at least 80% confidence that the true response rate exceeds 15% and that this approach is potentially efficacious.
Time frame: Up to 5 years
Transplant-related mortality
Defined as death before day 200 not related to progression of disease.
Time frame: Within 200 days of transplant
Rate of grade IV acute GVHD
Time frame: Up to 90 days after last T-cell infusion
Survival
Will be examined separately and reported in a descriptive manner and confidence intervals will be presented.
Time frame: Up to 5 years
Incidence of relapse
Will be examined separately and reported in a descriptive manner and confidence intervals will be presented.
Time frame: Up to 5 years
Incidence of myelosuppression after initial PBSC infusion
Defined as absolute neutrophil count \< 500 for \> 2 days, platelets \< 20,000 for \> 2 days. Will be examined separately and reported in a descriptive manner and confidence intervals will be presented.
Time frame: Up to 2 months post-transplant
Incidence of aplasia after DLI
Will be examined separately and reported in a descriptive manner and confidence intervals will be presented.
Time frame: Until 2 months post-transplant
Incidence of grades 2-4 acute GVHD after DLI
Will be examined separately and reported in a descriptive manner and confidence intervals will be presented.
Time frame: Up to 90 days after last T-cell infusion
Incidence of grades chronic extensive GVHD after DLI
Will be examined separately and reported in a descriptive manner and confidence intervals will be presented for all estimates.
Time frame: Up to 90 days after last T-cell infusion
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center