Stage IV Renal Cell Cancer Clinical Trial
Official title:
Phase I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma. A Multi-Center Trial.
Verified date | July 2019 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 27, 2018 |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 74 Years |
Eligibility |
Inclusion Criteria: - Patients with histologically confirmed stage IV renal cancer who have stable (including those rendered to be in remission) or progressive disease - Human lymphocyte antigen (HLA) genotypically identical related donor willing to undergo leukapheresis initially for collection of peripheral blood stem cells (PBSC) and subsequently for collection of peripheral blood mononuclear cells (PBMC) - Ionized calcium level within normal limits - DONOR: HLA genotypically identical family member (excluding identical twins) - DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis - DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) - DONOR: Age < 75 years Exclusion Criteria: - Patients who have positive serologies for human immunodeficiency virus (HIV)1 and 2, human T-lymphotropic virus (HTLV)-1 - Patients unwilling to use contraceptive techniques during and for 12 months following treatment - Serum creatinine > 2.0; the Fred Hutchinson Cancer Research Center (FHCRC) Patient Care Conference (PCC) may approve patients with elevated serum creatinine following presentation and approval; centers outside the FHCRC that have a PCC or equivalent should obtain their institutional approval; if there is not a comparable group at the institution, please contact the FHCRC Principal Investigator for FHCRC approval through PCC - Cardiac ejection fraction < 50%; ejection fraction is required if the patient has a history of anthracyclines or history of cardiac disease - Diffusion capacity of carbon monoxide (DLCO) < 50% of predicted, total lung capacity (TLC) < 50%, forced expiratory volume in one second (FEV1) < 50% - Liver function tests including total bilirubin, serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 x the upper limit of normal unless due to the malignancy - Karnofsky score < 80 - Brain metastasis - Ongoing active bacterial, viral or fungal infection - Pregnancy or breastfeeding - Patients with other active non-hematologic malignancies (except non-melanoma skin cancers) - Patients with a history of other non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence - The addition of cytotoxic agents for "cytoreduction" with the exception of Gleevec (imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning - DONOR: Age less than 12 years - DONOR: Pregnancy - DONOR: Infection with HIV - DONOR: Inability to achieve adequate venous access - DONOR: Known allergy to G-CSF - DONOR: Current serious systemic illness - DONOR: Failure to meet criteria for donation as described in the Standard Practice Guidelines of the institution |
Country | Name | City | State |
---|---|---|---|
United States | Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado |
United States | Baylor University Medical Center | Dallas | Texas |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
United States | VA Puget Sound Health Care System | Seattle | Washington |
United States | University of Arizona Health Sciences Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 5 years | |
Primary | Transplant-related mortality | Defined as death before day 200 not related to progression of disease. | Within 200 days of transplant | |
Primary | Rate of grade IV acute GVHD | Up to 90 days after last T-cell infusion | ||
Secondary | Survival | Will be examined separately and reported in a descriptive manner and confidence intervals will be presented. | Up to 5 years | |
Secondary | Incidence of relapse | Will be examined separately and reported in a descriptive manner and confidence intervals will be presented. | Up to 5 years | |
Secondary | 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. | Up to 2 months post-transplant | |
Secondary | Incidence of aplasia after DLI | Will be examined separately and reported in a descriptive manner and confidence intervals will be presented. | Until 2 months post-transplant | |
Secondary | 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. | Up to 90 days after last T-cell infusion | |
Secondary | 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. | Up to 90 days after last T-cell infusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
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