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Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer 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 Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer 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 Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer 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 Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare possible for their Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer 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.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer  Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
For Condition: Melanoma,ovarian epithelial cancer,myelodysplastic and myeloproliferative disease,Non-small cell lung cancer,atypical chronic myeloid leukemia,acute leukemia
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer.
Details: OBJECTIVES: - Determine the safety of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndromes, or non-small cell lung cancer previously treated with sargramostim (GM-CSF)-based autologous tumor vaccines. - Determine, preliminarily, the biologic activity and efficacy of this drug in these patients. OUTLINE: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 3 months in the absence of disease progression or unacceptable toxicity. Patients are followed monthly until disease progression. PROJECTED ACCRUAL: A total of 48 patients (12 per disease type) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Ovarian epithelial cancer - Persistent or recurrent disease after primary surgery and chemotherapy - Melanoma - Stage IV disease - Acute myeloid leukemia (AML) meeting 1 of the following criteria: - Second relapse - First relapse with no option for bone marrow transplantation - Ineligible for immunosuppressive chemotherapy due to age or comorbid disease - Myelodysplastic syndromes (MDS) - Non-small cell lung cancer - Incurable by standard surgery, chemotherapy, and/or radiotherapy - Disease previously treated with sargramostim (GM-CSF)-based vaccine therapy using lethally irradiated autologous tumor cells - No standard curative treatment exists - No immediate palliative therapy required - Measurable disease - No CNS metastases unless previously treated and stable for at least 3 months PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC greater than 1,000/mm^3* - Platelet count greater than 75,000/mm^3* NOTE: * Except for patients with AML/MDS Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - AST and ALT less than 2 times ULN Renal: - Creatinine less than 2 mg/dL Immunologic - No active infection - No autoimmune disease requiring immunosuppressive treatment - No active autoimmune disease threatening vital organ function - No significant history of autoimmune disease that could be reactivated, including any of the following: - CNS (e.g., multiple sclerosis) - Eye (e.g., uveitis) - Intestine (e.g., irritable bowel disease) - Liver (e.g., hepatitis) - Kidney - Connective tissue disease (e.g., systemic lupus erythematosus, scleroderma, or polymyositis) - Heart (e.g., myocarditis) - Possible autoimmune diseases that are managed with replacement therapy are allowed (e.g., diabetes mellitus or hypothyroid) Other: - No underlying medical condition that would preclude study participation - No concurrent medical condition requiring systemic steroids - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy - No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy: - At least 4 weeks since prior hormonal therapy - At least 4 weeks since prior systemic corticosteroids - Concurrent inhaled or topical steroids allowed Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgical procedures Other: - At least 4 weeks since other prior therapy - Recovered from prior therapy - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
F.Hodi, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting F. Hodi 617-632-5053
Additional Information:
Study ID Numbers: CDR0000069349; DFCI-NCI-5708,NCI-5708
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039091
Other Atypical Chronic Myeloid Leukemia Studies:
1. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
2. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
3. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
4. T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia
5. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
Related Studies:
Other atypical chronic myeloid leukemia Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
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