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

To: Henry Niman who wrote (14195)	2/4/1998 9:03:00 AM
From: Henry Niman	Respond to of 32384

Notice that JoAnne Zujewski is running one of the combination trials using Panretin (9-cis-Retinoic Acid) and Tamoxifen for treating breast cancer (and its paid for by the government): More trials are linked at home.att.net including another combination trial with Panretin and Tamoxifen for breast cancer. Phase I Study of 9-cis-Retinoic Acid and Tamoxifen in Advanced Breast Cancer Summary Last Modified: 12/97 Protocol IDs: NCI-96-C-0080B, NCI-T95-0090N, NCI-96-C-0080A Protocol Type: treatment Sponsorship: NCI-sponsored, NCI CTEP-approved Status: Active Age Range: 18 and over PROJECTED ACCRUAL: Up to 18 patients will be enrolled at the rate of 1 patient per month. OBJECTIVES: I. Estimate the maximally tolerated dose of 9-cis-retinoic acid (9-CRA) when given with tamoxifen (TMX) in patients with advanced breast carcinoma. II. Determine the overall and dose-limiting toxic effects of this combination. III. Describe the effect of TMX on the pharmacokinetics of 9-CRA. IV. Evaluate the antitumor activity of 9-CRA/TMX within a phase I study. V. Describe the effect of 9-CRA/TMX on the expression of the surrogate biomarkers tumor growth factor-beta-1, -beta-2, and -beta-3; retinoic acid receptors; and retinoid X receptors. PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically documented breast carcinoma Stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal Either ER/PR-positive or -negative tumor allowed if postmenopausal Stage IV with ER/PR-positive or -negative tumor No CNS metastases --Prior/Concurrent Therapy-- Recovered from all prior therapy Prior tamoxifen allowed At least 3 weeks since chemotherapy --Patient Characteristics-- Age: 18 and over Sex: Men and women Menopausal status: Any status Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 90,000/mm3 Hepatic: In the absence of tumor involvement: Bilirubin no greater than twice normal AST no greater than twice normal Alkaline phosphate no greater than twice normal Fasting triglycerides less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No seizures No pseudotumor cerebri No allergy to study medications No nonmalignant systemic disease that would preclude therapy No second malignancy within 5 years except: Curatively treated basal cell skin carcinoma Cervical carcinoma in situ No pregnant women Negative pregnancy test required within 7 days prior to entry Adequate contraception required for 4 weeks prior to, during, and for 1 year after study PROTOCOL OUTLINE: This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 9 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate. WARNING: Many protocols are potentially hazardous, are intended only 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 protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board. PARTICIPATING ORGANIZATIONS/INVESTIGATORS JoAnne Zujewski, Chair, Ph: 301-496-4916 Division of Clinical Sciences