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A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastases

Thank you

Trial Information

A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma


Inclusion Criteria:



- Sign an Institutional Review Board (IRB)-approved informed consent.

- Metastatic colorectal adenocarcinoma that has been pathologically confirmed following
failed response or relapse while on or following fluoropyrimidine, irinotecan, and
oxaliplatin chemotherapy. (Prior therapy with cetuximab is recommended if the tumors
are epidermal growth factor receptor [EGFR] positive.)

- Age 18 or above.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.

- Recovered to baseline toxicity from any significant toxicity associated with prior
surgery, chemotherapy, biological therapy, or investigational drug.

- Adequate bone marrow reserve (absolute neutrophil count > 1500 cells/mm3, platelet
count > 125,000 cells/mm3, hemoglobin concentration ≥ 10 g/dL).

- Radiographically measurable disease (RECIST criteria).

- Life expectancy of at least 3 months.

- Male and female subjects of reproductive potential must agree to follow accepted
birth control methods, as determined by the investigator, during treatment and for 12
months after completion of treatment.

Exclusion Criteria:

- Prior radioimmunotherapy.

- Known presence of central nervous system (CNS) metastasis.

- Any lesion > 7.5 cm.

- Total bilirubin > 2.0 mg/dL.

- Total creatinine > 2.0 mg/dL.

- AST and ALT > 2.5 times upper limit of normal (ULN), if metastases to the liver > 5
times ULN.

- Presence of a second primary malignancy requiring active treatment (except for
hormonal therapy).

- Serious non-malignant disease or infection that, in the opinion of either the
investigator or sponsor, would compromise protocol objectives.

- History of external beam radiation therapy to > 25% of active bone marrow.

- History of bone marrow or stem cell transplant.

- History of granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage
colony stimulating factor (GM-CSF) therapy within 2 weeks before Study Day 1.

- History of pegylated G-CSF therapy within 4 weeks before Study Day 1.

- History of major surgery, other than diagnostic surgery, within 4 weeks of Study Day
1.

- History of receiving investigational product within 4 weeks before Study Day 1 or
long term toxicity from a previous investigational therapy.

- Known history of HIV or AIDS.

- Concurrent systemic corticosteroid therapy or other immunosuppressive agents, unless
for the treatment of computed tomography (CT) dye allergy reactions.

- Pregnant or lactating female.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.

Principal Investigator

Andres Forero, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center, University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

159-01

NCT ID:

NCT00102024

Start Date:

January 2005

Completion Date:

January 2006

Related Keywords:

  • Colorectal Cancer
  • Metastases
  • Metastatic Colorectal Adenocarcinoma
  • Anti TAG-72
  • Monoclonal Antibody
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300