Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC)
NCT00006347CI-TRIAL-00002105unknownPhase 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 monoclonal antibody therapy in treating patients who have relapsed or refractory 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 small cell lung cancer (SCLC) * Must have received at least one prior course of standard chemotherapy and, if indicated, up to 6,900 cGy of thoracic radiotherapy * Patients who received prior radiotherapy must show evidence of progressive disease * Patients who received no prior radiotherapy to the primary tumor must show evidence of stable or progressive disease * Measurable 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 unilateral bone marrow biopsy with less than 25% tumor involvement * 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/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 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% Pulmonary: * FEV\_1 and FVC at least 60% * DLCO at least 50% predicted 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 * No active HIV-related disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months following study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No concurrent growth factors (e.g., filgrastim \[G-CSF\]) Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No prior high dose chemotherapy with stem cell transplantation Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * Prior radiotherapy to less than 30% of red marrow (including standard chest x-ray for limited stage SCLC) allowed Surgery: * At least 4 weeks since prior major surgery
References
Publications (0)
Data not yet available
No reference posted for this study.