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Home > "S" Clinical Trials Conditions > Stem Cell Transplant for Advanced Renal Cell Cancer  Stem Cell Transplant for Advanced Renal Cell Cancer
Stem Cell Transplant for Advanced Renal Cell Cancer
For Condition: Neoplasm Metastasis,Renal Cell Carcinoma
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: Metastatic Renal Cell Carcinoma (RCC) is an uncontrolled growth of renal cells, the cells which normally exist in the kidney. These cancerous cells can spread (metastasize) from the original kidney tumor site to other organs such as the bones, lymph nodes, liver, lungs, and brain. Once these organs become involved, the uncontrolled growth of cells can lead to organ failure and death. There are several treatments available for RCC that can be successful. However, once RCC has spread to other organs it is rarely curable. Surgery can be used to treat RCC, but in many patients the disease has spread too much to be removed by surgery. Medical treatment with chemotherapy can be used to treat RCC, but it has been relatively unsuccessful for patients whose cancer has spread to other organs. Bone marrow transplants (BMT) have been used to treat cancers of the blood and bone marrow. However, BMTs are usually combined with powerful doses of chemotherapy and radiation therapy. These additional treatments are associated with toxic side effects, often making BMTs too dangerous to attempt in many patients. The effectiveness of BMT on solid tumors, like RCC, has not been well studied. Researchers are interested in learning more about the potential benefits of modified bone marrow transplant (allogenic stem cell transplantation) for patients with advanced renal cell cancer. In this study researchers plan to treat patients with advanced RCC with transplanted stem cells from a genetically matched brother or sister. These stem cells are healthy cells collected from the bone marrow of the patient's relative. Once the stem cells are transplanted they help to make new blood cells. In addition, immune factors found in the transplant can work to destroy cancerous cells. In order to avoid the toxic side effects normally associated with BMT, the stem cell transplant will be combined with low intensity chemotherapy. The majority of the cancer killing effect will be the responsibility of the stem cell transplant rather than the chemotherapy.
Details: The current treatment of patients with stage IV renal cell carcinoma (RCC) is unsatisfactory. No chemotherapeutic agents currently exist which are effective in the treatment of metastatic RCC. In vitro studies have shown that malignant renal cells are immunogenic and can be killed by tumor-specific cytotoxic lymphocytes. These findings form the basis of immunotherapeutic strategies for patients with metastatic kidney cancer. However, such approaches are currently ineffective for the majority of patients with metastatic RCC. For many adult leukemias allogeneic bone marrow transplantation (ABMT) is the only curative modality. In vitro studies have implicated donor-derived CD4 and CD8 positive lymphocytes with specific reactivity for the patient's leukemia and a powerful anti-leukemic, or graft versus leukemia (GVL) effect. This GVL effect is best seen in patients with relapsed CML after bone marrow transplantation where a single infusion donor lymphocytes can induce complete and lasting remission. Malignant renal cells as known targets for autologous T-cell attack could similarly be susceptible to a powerful allogeneic graft versus tumor effect. In this study we will treat patients with progressive RCC with an allogeneic stem cell transplant from an HLA matched family member in attempts to exploit the immunogenicity of malignant renal cells. The allogeneic immune system established after transplant would have the advantage of not being "tolerized" to the patient's tumor and may recognize alloantigens on tumor cells which are not part of the repertoire of the host's immune surveillance. A low intensity, nonmyeloablative conditioning regimen will be used to minimize transplant associated toxicity, while providing adequate immunosuppression to allow stem cell and lymphocyte engraftment. A T-cell replete, donor derived granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSC) will be used to establish hematopoietic and lymphoid immune reconstitution. We will infuse lymphocytes in patients with <100% donor T-cell chimerism in an attempt to prevent graft rejection. Cyclosporine and methotrexate will be used as prophylaxis for graft versus host disease (GVHD). Cyclosporine will be reduced in patients who develop progressive RCC in the absence of GVHD to enhance a possible graft-versus-tumor (GVT) effect. Should disease progression continue (in the absence of GVHD), patients will receive an infusion of donor lymphocytes as a further attempt to obtain a GVT effect. The end points of this study are disease response, engraftment, degree of donor-host chimerism, incidence of acute and chronic GVHD, transplant related morbidity and morality as well as disease-free and overall survival.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - PATIENT: Ages 18-80 years. Biopsy proven metastatic RCC, not amenable to complete surgical resection, progressive bidimensionally evaluable clinically or radiographically. No prior treatment for RCC within 30 days. HIV negative. ECOG performance status of 1 or less. No major organ dysfunction precluding transplantation. DLCO greater than or equal to 65% predicted. Left ventricular ejection fraction greater than or equal to 40%. HLA 6/6 or 5/6 matched family related donor available. Informed consent given. Durable power of attorney signed. INCLUSION CRITERIA - DONOR: HLA 6/6 or 5/6 matched family related donor. Fit to receive G-CSF and give peripheral blood stem cells (normal blood counts, normotensive, no history of stroke). Informed consent given. Ages 18-80. EXCLUSION CRITERIA (any of the following) - PATIENT: Patient Pregnant. Age greater than 80 or less than 18 years. ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the patient or donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from BMT where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months). DLCO less than 65% predicted. Left ventricular ejection fraction less than 40%. Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hour urine collection. Serum bilirubin greater than 4 mg/dl, transaminases greater than 3 x upper limit of normal. HIV positive. History of other malignancies except basal cell or squamous carcinoma of the skin. Disease which is limited and amenable to complete surgical resection. Lack of evidence for progressive disease. Disease which is not evaluable clinically or radiographically. Evidence for CNS metastatic disease. Disease involving greater than 25% of the liver radiographically. Hypercalcemia (greater than 2.5 mmol/L). EXCLUSION CRITERIA - DONOR: Donor pregnant or lactating. Donor HIV or HBsAg positive. History of malignancy within 5 years except basal cell or squamous carcinoma of the skin. Donor unfit to receive G-CSF and undergo apheresis (Uncontrolled hypertension, history of stroke, thrombocytopenia).
Total Enrollment: 80
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 970196; 97-H-0196
Study Start Date: September 25, 1997
Record last reviewed: September 24, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001635
Other Neoplasm Metastasis Studies:
1. Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer
2. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
3. Stem Cell Transplant for Advanced Renal Cell Cancer
4. Phase I Study of PEG-Paclitaxel In Patients with Advanced Solid Tumors & Lymphomas
5. Treatment of Patients with Cancer with Genetically Modified Salmonella Typhimurium Bacteria
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Stem Cell Transplant for Advanced Renal Cell Cancer
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