Expired Study
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Madison, Wisconsin 53792


Purpose:

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have refractory advanced solid tumors or lymphoma.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose (MTD) of monoclonal antibody anti-alpha V beta 3 integrin (MEDI 522) in patients with refractory advanced solid tumors or lymphoma. - Determine the safety and tolerability of this drug in these patients. - Demonstrate significant binding of this drug to its molecular target in vivo in these patients. - Determine the effects of this drug on angiogenesis in these patients. - Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody anti-alpha V beta 3 integrin (Medi 522) IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor or lymphoma that is refractory to currently available standard therapies or for which there are no curative therapies - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No prior bleeding disorder Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal - INR/PTT normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation - HIV negative - T4 or thyroid stimulating hormone normal - No thyroid disease - No prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (e.g., rituximab or immunoglobulin G) - No ongoing or active infection - No other uncontrolled concurrent illness that would preclude study participation - No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered Surgery - More than 4 weeks since prior surgery Other - No other concurrent investigational agents - No other concurrent anticancer agents or therapies (commercial or investigational)


NCT ID:

NCT00049712


Primary Contact:

Study Chair
Douglas McNeel, MD, PhD
University of Wisconsin, Madison


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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