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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer Clinical research trials and Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer  Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer,renal granular cell carcinoma,renal clear cell carcinoma
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI),Southwest Oncology Group,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.
Details: OBJECTIVES: - Determine the overall response rate and overall and disease-free survival of patients with unresectable or metastatic renal cell cancer treated with fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation. - Determine the toxicity and treatment-related mortality of this regimen in these patients. - Determine the percentage of donor chimerism in patients treated with this regimen. OUTLINE: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6. After day 120, patients with persistent disease and no signs of active GVHD may receive donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2 infusions. Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every 2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma (RCC) - Clear cell or papillary RCC - Granular tumors with sarcomatoid features - No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma - No transitional cell carcinoma of the renal pelvis and collecting systems - Metastatic or unresectable disease - At least 1 measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are not considered measurable: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Primary bladder masses - Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies - No prior or concurrent CNS metastases - Negative MRI of the brain within the past 28 days - Must have HLA-identical (6/6) sibling donor PATIENT CHARACTERISTICS: Age: - 60 and under Performance status: - ECOG 0-1 Life expectancy: - More than 6 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal: - Creatinine clearance at least 40 mL/min Cardiovascular: - LVEF at least 45% by MUGA or echocardiogram Pulmonary: - DLCO greater than 40% of predicted (corrected for hemoglobin level) - No symptomatic pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No known hypersensitivity to E. coli-derived products - No uncontrolled diabetes mellitus - No active serious infection - No other concurrent malignancy except non-melanoma skin cancer or other malignancy that has less than a 30% risk of relapse after completion of therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent sargramostim (GM-CSF) - Concurrent epoetin alfa allowed Chemotherapy: - No other concurrent chemotherapy Endocrine therapy: - At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy) - Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy: - At least 14 days since prior radiotherapy Surgery: - At least 14 days since prior surgery Other: - At least 28 days since prior systemic therapy for RCC - Recovered from prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimMargolin, Study Chair, Beckman Research Institute
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Additional Information:
Study ID Numbers: CDR0000069044; SWOG-CALGB-C90003,ECOG-CALGB-C90003,CALGB-90003
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027573
Other Recurrent Renal Cell Cancer Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
2. PS-341 in Treating Patients With Metastatic Kidney Cancer
3. BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
4. Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
5. Tretinoin Plus Interferon alfa in Treating Patients With Metastatic Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
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