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Home > "S" Clinical Trials Conditions > Study of Peripheral Stem Cell Transplantation After Chemotherapy and Radiation Therapy in Treating Patients With Metastatic Kidney Cancer  Study of Peripheral Stem Cell Transplantation After Chemotherapy and Radiation Therapy in Treating Patients With Metastatic Kidney Cancer
Study of Peripheral Stem Cell Transplantation After Chemotherapy and Radiation Therapy in Treating Patients With Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Donor white blood cellinfusions may decrease the body's immune response to transplanted peripheral stem cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy, radiation therapy, peripheral stem cell transplantation, and donor white blood cells in treating patients who have metastatickidney cancer.
Details: OBJECTIVES: - Determine if mixed or full donor hematopoietic chimerism can be safely achieved with nonmyeloablative conditioning therapy in patients with metastatic renal cell carcinoma. - Determine if mixed chimerism can be safely converted to full donor hematopoietic chimerism with donor lymphocyte infusions in this patient population. - Determine the efficacy of this treatment regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive fludarabine IV on days -4 to -2 and undergo total body irradiation followed by filgrastim (G-CSF)-mobilized HLA-matched allogeneic peripheral blood stem cell transplantation on day 0. Patients receive immunosuppressive therapy comprising oral cyclosporine twice daily beginning on day -3 and continuing until day 35 followed by a taper until day 56. Patients also receive oral mycophenolate mofetil three times daily on days 0-40. Patients with stable mixed chimerism on day 56 and no evidence of graft-vs-host disease may receive escalating doses of nonmobilized T-cell donor lymphocyte infusion (DLI) over 30 minutes. Patients may receive up to 4 DLIs if there is evidence of disease progression. Patients are followed weekly for 3 months, monthly for 3 months, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV renal cell carcinoma - Stable or progressive disease - HLA genotypically identical related donor - No identical twins - No brain metastasis PATIENT CHARACTERISTICS: Age: - Under 75 Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN)* - SGOT and SGPT no greater than 2 times ULN* NOTE: * Unless due to malignancy Renal: - Creatinine no greater than 2.0 mg/dL - Calcium normal Cardiovascular: - Ejection fraction at least 50% Pulmonary: - DLCO at least 50% of predicted Other: - HIV-1 and HIV-2 negative - HTLV-1 negative - No ongoing active bacterial, viral, or fungal infection - Not pregnant - Fertile patients must use effective contraception during and for 12 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent growth factors during mycophenolate mofetil administration Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaSandmaier, Study Chair, Fred Hutchinson Cancer Research Center
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Christopher Bredeson 414-456-8325
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Brenda Sandmaier 206-667-4961
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-224-0421
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-820-1800
Additional Information:
Study ID Numbers: CDR0000067873; NCI-G00-1790,FHCRC-1495.00
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005851
Other Stage 4 Renal Cell Cancer Studies:
1. PEG-Interferon alfa-2b in Treating Patients With Metastatic Kidney Cancer
2. Interferon alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
3. Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer
4. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
5. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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Study of Peripheral Stem Cell Transplantation After Chemotherapy and Radiation Therapy in Treating Patients With Metastatic Kidney Cancer
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