Clinical trial · Interventional
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT00006458CI-TRIAL-00002102unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have relapsed or refractory non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indium In 111 monoclonal antibody MN-14 | Radiation | — | UNRESOLVED |
| yttrium Y 90 monoclonal antibody MN-14 | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Adenocarcinoma, squamous large cell, or mixed cell histology Patients with nonadenocarcinomatous disease must have evidence of carcinoembryonic antigen (CEA) production or expression documented by one of the following: Serum CEA at least 10 ng/mL Positive immunohistology of either the primary tumor or a metastasis with CEA-specific monoclonal antibody Must have received at least one prior regimen of standard chemotherapy and, if indicated, no greater than 6,900 cGy thoracic radiotherapy Patients with stage IIIA/B unresectable disease who received prior radiotherapy must show evidence of progressive disease (greater than 25% increase in primary tumor or appearance of new lesions) Patients with stage IIIB or IV disease who received no prior radiotherapy to the primary or index lesion must show evidence of stable or progressive disease by CT scans at least 4 weeks apart Less than 25% tumor involvement in bone marrow No known, active brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST no greater than 2 times upper limit of normal (ULN) No hepatitis B or C No other serious liver abnormality Renal: Creatinine no greater than 1.5 times ULN No urinary incontinence Cardiovascular: Ejection fraction at least 50% by MUGA Pulmonary: FEV1 at least 60% DLCO at least 50% Other: No severe anorexia, nausea, or vomiting No other significant medical problems No prisoners No reactivity to humanized MN-14 (in patients with prior exposure to chimeric or humanized antibody) HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation after high-dose chemotherapy No concurrent growth factors Chemotherapy: See Disease Characteristics See Biologic At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Prior radiotherapy to less than 30% of red marrow allowed Surgery: At least 4 weeks since prior major surgery
References
Publications (0)
Data not yet available
No reference posted for this study.