Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Study Of Medi 522 In Patients With Advanced Tumors

Conditions
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Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: etaracizumab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: etaracizumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, small intestine lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, unspecified adult solid tumor, protocol specific, stage IV adult lymphoblastic lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Burkitt lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III mycosis fungoides/Sezary syndrome, stage III adult T-cell leukemia/lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma