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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. VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin

2. Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

3. Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors

4. Valeriana Officinalis (Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

5. Bortezomib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
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