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Completed NCT00645060

Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: City of Hope Medical Center

Location: City of Hope Comprehensive Cancer Center Duarte California

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. This may be an effective treatment for advanced cancer. PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00645060). StuddyBuddy aggregates publicly available trial information.