|
Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma Clinical research trials and Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma. Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma clinical trial. Human subjects often get the best healthcare possible for their Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma  Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
For Condition: Breast Cancer,hematopoietic and lymphoid cancer,skin tumor,kidney and urinary cancer
Status: Recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Peripheral stem cell transplantation replaces immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the cells with a monoclonal antibody may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus monoclonal antibody therapy in treating patients who have high-risk hematologic cancer, refractory breast or kidney cancer, or melanoma.
Details: OBJECTIVES: - Determine the efficacy, in terms of mortality, occurrence of acute graft versus-host-disease, and grade 3/4 toxicity, of in vivo and in vitro alemtuzumab (monoclonal antibody CD52; Campath-1H) administered concurrently with nonmyeloablative fludarabine and cyclophosphamide, followed by HLA identical matched sibling allogeneic peripheral blood stem cell transplantation in patients with hematologic malignancies or refractory breast or renal cell cancer or melanoma. - Determine the engraftment rate, response rate, and long term survival of patients receiving this regimen. - Determine the recovery of immune function post engraftment in patients treated with this regimen. - Determine the pharmacokinetics of cyclophosphamide administered in this regimen. - Assess graft-versus-tumor effects in patients treated with this regimen. OUTLINE: Patients receive alemtuzumab (monoclonal antibody CD52; Campath-1H) IV over 3 hours on days -6 to -2 and fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic peripheral blood stem cells and alemtuzumab are infused on days 0 and 1. Filgrastim (G-CSF) is administered subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed daily until day 60, twice a week until day 100, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of any one of the following: - Relapsed or refractory hematologic malignancy - Acute myeloid leukemia - Chronic myeloid leukemia - Acute lymphocytic leukemia - Chronic lymphocytic leukemia - Multiple myeloma - Myeloproliferative or myelodysplastic disorders - Not eligible for full myeloablative matched sibling transplant - Bone marrow failure - Severe or very severe aplastic anemia - Myelofibrosis or paroxysmal nocturnal hemoglobinuria - Increased blast cells (at least 5%) in peripheral blood or bone marrow OR - Visceral organ damage due to disease - Severe fibrosis of bone marrow - Severe Budd-Chiari - Mild hepatic/portal clot by ultrasound or hepatic biopsy - Drug induced marrow aplasia - Hemoglobinopathies - Severe sickle cell anemia - Thalassemia with cardiac or hepatic damage - Solid tumor with metastatic disease and failed at least 1 standard regimen - Breast cancer - Progressed after doxorubicin and cyclophosphamide - Renal cell cancer - Failed interleukin-2 therapy - Melanoma - Failed interleukin-2 therapy - Must have 6/6 HLA matched sibling donor - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Not specified Menopausal status: - Not specified Performance status: - CALGB 0-2 Life expectancy: - At least 6 weeks Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - Ejection fraction greater than 40% Pulmonary: - DLCO greater than 40% Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other major medical or psychiatric illness that would preclude compliance - No allergy to murine protein - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - Recovered from prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Recovered from prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidRizzieri, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting David Rizzieri 919-668-1040
Additional Information:
Study ID Numbers: CDR0000067374; DUMC-1340-99-7,NCI-G99-1617
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004143
Other Hematopoietic And Lymphoid Cancer Studies:
1. Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma
2. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
3. Total-Body Irradiation and Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Kidney Cancer
4. Docetaxel in Treating Patients With Solid Tumors
5. Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
Related Studies:
Other hematopoietic and lymphoid cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
|
|
|
|
|
|
|
|
