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Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer Clinical research trials and Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer. Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer  Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
For Condition: AIDS-related peripheral/systemic lymphoma
Status: No longer recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy. PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer.
Details: OBJECTIVES: - Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies. - Determine the immune status of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of stem cell factor. Patients receive interleukin-2 (IL-2) subcutaneously (SC) six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 3 patients receives treatment at the MTD. Patients are followed every 2 weeks for 1 month. PROJECTED ACCRUAL: A total of 3-18 patients 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 HIV-1 by ELISA, Western blot, polymerase chain reaction, or other documentation - Must have had 1 of the following AIDS-defining illnesses: - Opportunistic infection - Opportunistic malignancy (excluding CNS involvement) - CD4 T-cell count less than 200/mm^3 (but currently greater than 20/mm^3) - Receiving antiretroviral therapy - No concurrent Kaposi's sarcoma - Prior Kaposi's sarcoma in complete response allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% Life expectancy - Not specified Hematopoietic - Absolute granulocyte count greater than 1,000/mm^3* - Hemoglobin at least 10 g/dL* - Platelet count greater than 50,000/mm^3* NOTE: *Transfusions and growth factors allowed in order to increase or maintain counts Hepatic - No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices - Bilirubin no greater than 2 mg/dL - INR no greater than 1.5 Renal - Not specified Cardiovascular - No prior angioedema - No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmHg) - No unstable angina - No New York Heart Association class III or IV heart disease - No congestive heart failure - No coronary angioplasty within the past 6 months - No myocardial infarction within the past 6 months - No uncontrolled atrial or ventricular cardiac arrhythmia Pulmonary - No history of seasonal or recurrent asthma within the past 10 years - No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection Immunologic - No prior positive allergy test (skin or radioallergosorbent test) for insect venoms - No known allergy to E. coli-derived products - No prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm - Drug allergies manifested solely by rash and/or urticaria allowed - No recurrent urticaria (isolated episode of urticaria allowed) - No other active uncontrolled infection (including one with current symptoms of bronchoconstriction) - No fever of 38.2° C or higher - Fevers due to B symptoms allowed Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior or concurrent CNS malignancy - No poorly controlled diabetes - No other significant nonmalignant disease - No other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy) PRIOR CONCURRENT THERAPY: Biologic therapy - See Hematopoietic in Patient Characteristics - No prior stem cell factor - No concurrent interleukin-11 for thrombocytopenia Chemotherapy - No concurrent chemotherapy for malignancy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No concurrent enrollment on any other protocol utilizing an investigational drug - No concurrent beta adrenergic blocking agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ZaleBernstein, Study Chair, Roswell Park Cancer Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000285694; RPCI-RP-9911
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058045
Other Aids-Related Peripheral/systemic Lymphoma Studies:
1. Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
2. Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma or High-Risk Stage I Non-Hodgkin's Lymphoma
3. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
4. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
5. Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Related Studies:
Other AIDS-related peripheral/systemic lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
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