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Home > "I" Clinical Trials Conditions > Investigating the Use of SS1(dsFv)-PE38 to Treat Advanced Malignancies  Investigating the Use of SS1(dsFv)-PE38 to Treat Advanced Malignancies
Investigating the Use of SS1(dsFv)-PE38 to Treat Advanced Malignancies
For Condition: Carcinoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The experimental drug SS1(dsFv)-PE38 has been used to treat cancers that have recurred or progressed. The purpose of this study is 1) to determine the side effects and highest tolerated dose of SS1(dsFv)-PE38, 2) to determine the blood levels of the drug, and 3) to test the efficacy of the drug in the treatment of several types of cancer. Approximately 40 participants age 18 years or older will participate in this study. Before the onset of treatment, they will undergo the following: a medical history, a physical exam, blood work, urinalysis, and a heart-function test. Participants will receive the study drug intravenously in 3 doses given every other day. The courses of treatment may be repeated every 4 weeks for a maximum of 3 treatment cycles. Doctors will monitor patients during their course of treatment via the following extensive testing procedures: echocardiogram, electrocardiogram, lung-function tests, chest x-ray, MRI scan, as well as the pre-treatment procedures and tests that participants underwent.
Details: Rationale: Tumor specific targeting of mesothelin expressing tumors with a chimeric immunotoxin. Administration QOD permits detection of normal tissue toxicity, if any, or recovery from subclinical toxicity. Primary Objective: To determine the maximum tolerated dose (MTD) and toxicities of SS1(dsFv)-PE38 by iv infusion QOD for 3 doses (MTD3) in patients with advanced malignancies. Secondary Objectives: To characterize plasma pharmacokinetics of SS1(dsFv)-PE38 after i.v. infusion. To determine toxicity to subsequent courses. To evaluate response of selected advanced malignancies to i.v. infusion of SS1(dsFv)-PE38 QOD for 3 doses. To document the induction of antibody against SS1(dsFv)-PE38 and its relationship to pharmacokinetics after administration of 3 doses. Safety Endpoints: The determination of dose limiting toxicities. Study Design: A Phase I, open-label, dose escalating study to determine the MTD of i.v. infusion of SS1(dsFv)-PE38 QOD x 3 starting dose will be 25 g/kg/day. Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed. The MTD3 will be defined as the dose level below that at which 2 of up to 6 patients experience DLT after QOD x 3 dosing. Number of Patients: Up to 40. Number of Sites: 1: The National Cancer Institute Patient Population: Patients with advanced solid tumors that express mesothelin.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histopathologic diagnosis of one of the following malignancies: Ovarian carcinoma, all non-mucinous epithelial histologies, including primary peritoneal and fallopian tube carcinoma; Malignant mesothelioma, except sarcomatous histology; Pancreatic cancer positive for mesothelin; Squamous cell cancer of the lung; Squamous cell cancer of the cervix; Squamous cell cancer of the head and neck. Tissue block must be available for analysis. Tumor, initial or recurrent, must be positive (greater than or equal to 30% of tumor cells) for mesothelin by immunohistochemistry. Recurrent unresectable disease after appropriate definitive therapy. Patients must have received prior therapy considered standard for their particular cancer, unless refused by the patient. At least 4 weeks since any prior therapy, with recovery from side effects. No concurrent anti-tumor treatment of any kind. Measurable or evaluable tumor documented within 4 weeks prior to study entry. Age greater than or equal to 18 years. Life expectancy greater than or equal to 12 weeks. Performance Status (ECOG) 0-2. Adequate organ function, including: ANC greater than or equal to 1,500/mm(3); Plts greater than or equal to 75,000/mm(3); Creatinine, Ca(2+) and total Bilirubin less than or equal to upper limit normal (ULN); AST (SGOT) and ALT (SGPT) less than or equal to 2.5 x ULN; Albumin greater than or equal to 3.0 gm/dL; Baseline O(2) saturation greater than or equal to 93% (room air); Pulmonary function tests (PFT), including FEV(1), TLC, DL(CO), and VC, greater than or equal to 50% of predicted value (for those patients with pleural mesothelioma and as clinically indicated). Informed consent, in accordance with institutional criteria, signed prior to any study specific procedures or assessments. EXCLUSION CRITERIA: Patient may not have any of the following: Any known CNS or spinal cord involvement by tumor. Serum neutralizing activity to SSI (dsFv)-PE38 at 200 ng/mL is greater than 75%. Concurrent antitumor therapy. Cardiovascular condition NY Heart Association Grade II-IV, or clinically-significant pericardial effusion. Any infection requiring parenteral antibiotics, history of HIV infection, or seropositivity for Hepatitis B and Hepatitis C. Be pregnant or nursing. Females of child-bearing potential must use an effective method of contraception.
Total Enrollment: 15
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030243; 03-C-0243
Study Start Date: July 23, 2003
Record last reviewed: January 6, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065481
Other Carcinoma Studies:
1. Investigating the Use of SS1(dsFv)-PE38 to Treat Advanced Malignancies
2. Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
Related Studies:
Other Carcinoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Investigating the Use of SS1(dsFv)-PE38 to Treat Advanced Malignancies
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