Non Hodgkin Lymphoma Clinical Trial
Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
Summary
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.
Full Description
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.
Eligibility 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)
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There is 1 Location for this study
Madison Wisconsin, 53792, United States
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