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Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors



Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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 advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. - Determine the potential anti-tumor activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated as above at that dose level. PROJECTED ACCRUAL: A total of 27-33 patients will be accrued for this study within 9-11 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists - Measurable or evaluable disease - Must have clinical or radiological evidence of disease - Disease must be accessible to biopsy and imaging studies - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - No prior bleeding disorder Hepatic - Bilirubin no greater than 1.2 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal (ULN) - PT/PTT no greater than ULN Renal - Creatinine less than 1.5 mg/dL 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 - Willing to be premedicated for delayed contrast-enhanced MRI - No prior claustrophobia - No dementia or altered mental status that would preclude informed consent - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situations that would preclude study compliance - No immunodeficiency - HIV negative - Must be willing to receive blood products - No thyroid disease - Thyroxine and thyroid-stimulating hormone no greater than ULN PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior taxanes allowed - No concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except: - Concurrent hormonal replacement therapy - Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 25% of the bone marrow - No concurrent radiotherapy Surgery - More than 4 weeks since prior surgery Other - No other concurrent investigational or commercial agents or therapies for the malignancy - No other concurrent antitumor therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PatriciaLoRusso,  Study Chair,  Harper Hospital

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201
United States
Recruiting Patricia  LoRusso 313-745-8860


Additional Information:
Study ID Numbers:  CDR0000258300;  WSU-C-2453,NCI-5496
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052403

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors

2. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

3. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

4. BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors

5. Gemcitabine and Flavopiridol in Treating Patients With Solid Tumors

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