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



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

For Condition: adult solid tumor,small intestine cancer,Leukemia,Lymphoma
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DouglasMcNeel,  Study Chair,  University of Wisconsin Comprehensive Cancer Center

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792
United States
Recruiting Douglas  McNeel 608-265-8131


Additional Information:
Study ID Numbers:  CDR0000257810;  WCCC-CO-01905,NCI-5497
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049712

Other Leukemia Studies:
1. BMS-247550 in Treating Patients With Advanced Cancers

2. Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer

3. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction

4. VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

5. XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma

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