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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Henry Niman who wrote (20560)	5/12/1998 11:02:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Here's SRGN's trial for patients who have failed 3 or fewer treatments: Phase III Randomized, Placebo-Controlled Study of Two Doses of the IL-2 Receptor-Targeted Cytotoxin DAB389-IL2 for Recurrent or Persistent Cutaneous T-Cell Lymphoma Summary Last Modified: 01/98 Protocol IDs: SERAGEN-93-04-11, NCI-V95-0740 Protocol Type: treatment Sponsorship: pharmaceutical Status: Active Age Range: 18 and over PROJECTED ACCRUAL: 120 patients will be randomized over approximately 30 months in this multicenter study. OBJECTIVES: I. Assess the degree, frequency, and duration of responses following treatment with the interleukin-2 (IL-2) receptor-targeted cytotoxin DAB389-IL2 given at two different doses (9 and 18 micrograms/kg/day) as second-line therapy for cutaneous T-cell lymphoma (CTCL). II. Assess changes in CTCL symptoms and functional status following treatment with DAB389-IL2. III. Evaluate further the safety and tolerability of this schedule of DAB389-IL2 at these doses. PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histopathologically confirmed cutaneous T-cell lymphoma Confirmation by reference pathology laboratory required Failed 1, 2, or 3 prior therapies (repeated use of same agent considered 1 therapy unless part of a different combination regimen), e.g.: Cyclosporine (at least 4 mg/kg/day for at least 1 month) Cytotoxic chemotherapy (including up to 1 combination regimen excluding steroids) Electron-beam radiotherapy Interferon Photopheresis Phototherapy (e.g., PUVA, UVB) Systemic retinoids Topical chemotherapy (e.g., carmustine, nitrogen mustard) Topical or systemic steroids not considered a therapy Tumor interleukin-2 receptor (IL-2R) expression determined by immunohistochemistry within 6 months prior to entry Biopsy required after most recent anticancer treatment Confirmation by central pathologist required Stage IA-III and unlikely to progress during the first month on study No high-grade/large cell tumors No poorly differentiated tumors No active CNS disease Measurable or evaluable disease (e.g., skin, blood, and/or lymph nodes) Lymph nodes 1 x 1 cm and less are not considered evaluable --Prior/Concurrent Therapy-- See Disease Characteristics No prior DAB389-IL2 or DAB486-IL2 At least 14 days between anticancer therapy and initiation of therapy Recovery with no further response expected At least 7 days between topical steroids and tumor burden assessment --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: At least 12 months Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL and clinically stable Hematocrit at least 30% (untransfused) Hepatic: Bilirubin normal AST no greater than 75 U/liter and stable ALT no greater than 100 U/liter and stable Alkaline phosphatase normal Albumin at least 3.0 g/dL Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance (calculated or measured) at least 50 mL/min AND Urine protein no greater than 2+ OR 24-hour urine protein less than 1 g/dL Cardiovascular: No NYHA class III/IV status No hypertension unless controlled on stable medication for at least 2 months Pulmonary: No significant pulmonary symptoms or disease Other: No history of uncontrolled seizure disorder Seronegative for HIV, HTLV-1, hepatitis C antibody, and HBsAg No requirement for parenteral antibiotics for active infection No requirement for aminoglycosides or amphotericin No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients Willing to be randomized to placebo-only treatment PROTOCOL OUTLINE: Randomized, double-blind study. Arm I: Targeted Fusion Protein Therapy. Genetically engineered interleukin-2 (IL-2) receptor-targeted cytotoxin consisting of enzymatically active diphtheria toxin fragment A, the membrane-translocating portion of diphtheria toxin fragment B, and IL-2 (DAB389-IL2). Arm II: Targeted Fusion Protein Therapy. DAB389-IL2. Alternate dose. Arm III: Control. Placebo, PLCB. Normal saline. WARNING: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening for or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. PARTICIPATING ORGANIZATIONS/INVESTIGATORS Patricia Bacha, Chair, Ph: 508-435-2331 Seragen, Inc. Principal Investigator(s)