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A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies


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 body, normal organs, and tumor through serial
nuclear imaging studies after intravenous infusion of the yttrium Y 90 DOTA anti-CEA
monoclonal antibody M5A.

OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA monoclonal antibody
M5A (MOAB M5A).

- Biodistribution: Patients receive indium In 111 radiolabeled anti-CEA MOAB M5A IV over
30 minutes. Patients undergo serial nuclear scans, single photon emission computed
tomography (SPECT), and blood and urine sampling over 1 week to estimate absorbed
radiation doses to tumor, normal organs (i.e., liver, lung, kidney, and bone marrow),
and whole body.

- Treatment: No more than 2 weeks later, patients with adequate biodistribution receive
yttrium Y 90 DOTA anti-CEA MOAB M5A IV over 30 minutes on day 1. Patients then undergo
serial nuclear scans, SPECT, and blood and urine sampling over 1 week to estimate
absorbed radiation doses to tumor, normal organs (i.e., liver, lung, kidney, and bone
marrow), and whole body. Treatment repeats every 6-10 weeks for up to 2 courses in the
absence of disease progression or unacceptable toxicity.

Blood and urine samples are collected periodically for analysis of total activity by
radiometric high performance liquid chromatography and to acquire data on antibody
metabolism and pharmacokinetics.

After completion of study treatment, patients are followed every 3 months for up to 6
months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

10 weeks after the beginning of the last cycle of treatment

Safety Issue:

Yes

Principal Investigator

Jeffrey Y. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

05198

NCT ID:

NCT00645060

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010