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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-07152 | |||
| CDR0000611960 | Registry Identifier | NCI PDQ | |
| NCI-2010-01232 | Registry Identifier | NCI CTRP (Clinical Trial Reporting Program) | |
| P01CA043904 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as carboplatin, paclitaxel, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving radiation therapy and combination chemotherapy together before radiolabeled monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled monoclonal antibody therapy when given after radiation therapy and combination chemotherapy in treating patients with stages I-IIIB non-small cell lung cancer.
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and associated toxicities of intravenous yttrium-90 (90Y) chimeric T84.66 (cT84.66) anti-carcinoembryonic antigen (CEA) antibody targeted radiotherapy delivered after carboplatin/paclitaxel or cisplatin/etoposide and external beam radiotherapy in patients with CEA positive stage III unresectable or medically inoperable non-small cell lung cancer.
SECONDARY OBJECTIVES: I. To collect data on the biodistribution, clearance and metabolism of 90Y (yttrium-90) and 111In (indium-111) chimeric T84.66 administered intravenously. II. To collect data on radiation doses to whole body, normal organs, and tumor through serial nuclear imaging.
OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CEA monoclonal antibody cT84.66.
CHEMORADIOTHERAPY: Patients undergo external beam radiation therapy 5 days a week for 45 days. Beginning within 24 hours of the start of radiation therapy, patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 OR cisplatin IV over 60 minutes on days 1, 8, 29, and 36 and etoposide IV over 60 minutes on days 1-5 and 29-33.
CONSOLIDATION RADIOIMMUNOTHERAPY: Beginning 6-10 weeks after completion of chemoradiotherapy, patients with stable disease, partial response, or complete response receive a therapeutic dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemo, monoclonal antibody therapy, radiation) | Experimental | CHEMORADIOTHERAPY: Patients undergo external beam radiation therapy 5 days a week for 45 days. Beginning within 24 hours of the start of radiation therapy, patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 OR cisplatin IV over 60 minutes on days 1, 8, 29, and 36 and etoposide IV over 60 minutes on days 1-5 and 29-33. CONSOLIDATION RADIOIMMUNOTHERAPY: Beginning 6-10 weeks after completion of chemoradiotherapy, patients with stable disease, partial response, or complete response receive a therapeutic dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV. Treatment continues in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high performance liquid chromatography | Other | Blood evaluation 0 minutes, 1 hour, 4 hours, 1 day, 2 days, 3-5 days and 6-7 days post start of antibody infusion. 24 hour urine sample evaluation daily for 5 consecutive days post antibody infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66 | 6 weeks after treatment | |
| Dose-limiting toxicity | 6 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 6 months after treatment | |
| Overall survival | 6 months after treatment | |
| Sites of recurrence |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Y. Wong, MD | City of Hope Medical Center | Principal Investigator |
| Marianna Koczywas, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| pharmacological study | Other | Blood evaluation 0 minutes, 1 hour, 4 hours, 1 day, 2 days, 3-5 days and 6-7 days post start of antibody infusion. 24 hour urine sample evaluation daily for 5 consecutive days post antibody infusion. |
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| radionuclide imaging | Procedure | Approximately 1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post infusion. |
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| single photon emission computed tomography | Procedure | Approximately 2 days and 3-5 days post infusion |
|
| radiation therapy | Radiation | 3-6 mCi Indium-111 labeled cT84.66(5mg) and dose escalation (depending on toxicities observed from previous dosages) from a starting dose of 8mCi/m2 Y-90-cT84.66. |
|
| yttrium Y 90 anti-CEA monoclonal antibody cT84.66 | Radiation | Dose escalation (depending on toxicities observed from previous dosages) from a starting dose of 8mCi/m2 Y-90-cT84.66. |
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| 6 months after treatment |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D002851 | Chromatography, High Pressure Liquid |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
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