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Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides Clinical research trials and Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides. Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides clinical trial. Participants typically obtain the most effective healthcare available for their Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides  Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
For Condition: Cutaneous T-Cell Lymphoma,mycosis fungoides and Sezary syndrome
Status: Recruiting
Sponsor(s): University of Pennsylvania Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies, such as interleukin-12 and interleukin-2, use different ways to stimulate the immune system and stop cancer cells from growing. Combining more than one biological therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides.
Details: OBJECTIVES: - Determine the response rate (complete and partial) in patients with mycosis fungoides treated with interleukin-12 (IL-12). - Determine the frequency of refractory disease in patients treated with this drug. - Determine the toxic effects of this drug in these patients. - Determine the feasibility and dose-limiting toxic effects (DLT) of interleukin-2 (IL-2) when administered with IL-12 in patients who have not shown disease progression after 12 weeks of IL-12 and in those who have shown disease progression after 12 weeks of IL-12. - Determine the maximum tolerated dose and recommended dose of IL-2 when administered with IL-12 in these patients. - Determine immune and cytokine response over time in patients treated with this regimen. - Determine the frequency of improved clinical response in patients treated with this regimen. - Determine the biologic correlates of response, including levels of interferon gamma production, natural killer cell activity, infiltration of skin lesions by CD8-positive cells, lymphocyte IL-12 receptor expression, signal transducers and activators of transcription protein levels and IL-12 signal transduction, and induction of apoptosis in tumor cells in the skin of patients treated with this regimen. OUTLINE: This is an open-label, multicenter, dose-escalation study of interleukin-2 (IL-2). Patients receive interleukin-12 (IL-12) subcutaneously (SC) twice weekly for 24 weeks. Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24. Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks. Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended dose (RD) is the dose preceding the MTD. Additional patients are treated at the RD. Patients are followed at 6 months. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 28 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed mycosis fungoides - Stage Ib-IV - At least 5% of total blood mononuclear cells must be CD8-positive lymphocytes - No CNS disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 6 months Hematopoietic - WBC 3,000/mm^3 but 40,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 10 g/dL (transfusion or epoetin alfa allowed) Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - AST and ALT 2 times ULN Renal - Creatinine 1.5 times ULN - Creatinine clearance 60 mL/min Cardiovascular - EKG normal - No known cardiac and peripheral vascular disease - No cardiac arrhythmias requiring medical treatment Pulmonary - Chest x-ray normal Immunologic - No history of or clinically significant autoimmune disease (e.g., rheumatoid arthritis), autoimmune hemolytic anemia, or positive Coombs' test - No HTLV-I or HTLV-II-associated disease - HIV negative - Antinuclear antibody negative - Rheumatoid factor negative - No serious concurrent infection requiring IV antibiotics Gastrointestinal - No clinically significant gastrointestinal bleeding - No uncontrolled peptic ulcer disease - No history of inflammatory bowel disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of peripheral neuropathy - No other major illness that would substantially increase the patient's risk PRIOR CONCURRENT THERAPY: Biologic therapy - Prior interferon allowed - Prior denileukin diftitox allowed - No prior interleukin (IL)-2 or IL-12 - No prior anti-T-cell monoclonal antibody therapy - No other concurrent biologic therapy Chemotherapy - Prior topical imidazole mustard or carmustine allowed - Prior bexarotene allowed - Prior oral methotrexate allowed - At least 3 weeks since prior topical chemotherapy - At least 8 weeks since prior treatment with any single chemotherapeutic agent (12 weeks for multiple chemotherapeutic agents) - Treatment must not have included steroids - No prior systemic chemotherapy - No prior fludarabine, pentostatin, or cladribine - No concurrent systemic chemotherapy Endocrine therapy - At least 3 weeks since prior topical or systemic steroids more potent than 1% hydrocortisone - No concurrent systemic corticosteroids - No concurrent low-potency steroid creams Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - At least 3 weeks since prior psoralen-ultraviolet-light (PUVA) or ultraviolet B (UVB) - At least 3 weeks since prior retinoids - At least 3 weeks since prior investigational drugs - Prior photopheresis allowed - No other concurrent investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlainRook, Study Chair, University of Pennsylvania Cancer Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Timothy Kuzel 312-695-4544
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Eric Vonderheid 410-955-5000
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Madeleine Duvic 713-745-1113
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Francine Foss 617-636-8884
University of Wisconsin *Recruiting*
Madison, Wisconsin, 53715-1375
United States
Recruiting Gary Wood 608-265-2943
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Alain Rook 215-662-6751
Additional Information:
Study ID Numbers: CDR0000258239; NCI-1831,UPCC-10401
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052377
Other Mycosis Fungoides And Sezary Syndrome Studies:
1. Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
2. Reduced-Intensity Regimen Before Bone Marrow Transplantation in Treating Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
3. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
4. Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
5. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
Related Studies:
Other mycosis fungoides and Sezary syndrome Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
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