Status:
COMPLETED
Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells....
Detailed Description
OBJECTIVES: * To establish the maximum tolerated dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A and describe the toxicities at each dose studied. * To estimate radiation doses to whole bo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed advanced solid tumor for which no standard or effective treatment is available
- Patients who refuse an available standard but non-curative treatment may also be eligible
- Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods
- Positive CEA IHC stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater
- Measurable disease
- Estimated \< 1/3 of liver involvement if tumor involves the liver
- No brain or leptomeningeal involvement with cancer
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 3 months
- WBC ≥ 4,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 125,000/μL
- Creatinine ≤ 1.5 mg/dL and/or creatinine clearance \> 60 mL/min
- Bilirubin ≤ 1.5 mg/dL
- ALT and AST ≤ 2 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception
- Patients currently being treated for severe infections or recovering from other intercurrent illnesses (such as poorly controlled diabetes or hypertension) are ineligible until recovery is deemed complete by the investigator
- Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody)
- Serum HIV-negative
- Serum hepatitis B antigen- and hepatitis C antibody-negative
- PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior radiotherapy, immunotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
- Recovered from prior major surgery
- No prior radiotherapy to \> 50% of bone marrow
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
Exclusion
Key Trial Info
Start Date :
October 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00645060
Start Date
October 9 2006
End Date
September 6 2016
Last Update
February 27 2020
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000