Status:
COMPLETED
TF2- Small Cell Lung Cancer Radio Immunotherapy
Lead Sponsor:
Centre René Gauducheau
Conditions:
Small Cell Lung Cancer
CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Lung cancer is currently the leading cause of cancer death in both men and women in Europe, with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients indicates that ...
Detailed Description
The purpose of this open-label prospective optimization and phase I/II clinical trial is to examine the safety, optimal dose, targeting, dosimetry and efficacy of PRAIT using the humanized anti-CEA x ...
Eligibility Criteria
Inclusion
- • Patients with histologic diagnosis of SCLC who are in partial response or who have failed at least two lines of standard radiation and/or chemotherapy. Outside formal contra-indication, patients must have received at least one prior platinum-based chemotherapy.
- or
- Patients with histologic diagnosis of NSCLC (without activating mutation of EGFR gene) who have failed at least one line of chemotherapy (platinum in combination with a third generation drug or combination of 2 third generation drug +/-bevacizumab in case of predominance of non-squamous tumor)
- Age ≥ 18 years
- At least 4-weeks after the previous treatment and have recovered from previous radio- or chemotherapy
- Women of child-bearing potential must have a negative pregnancy test.
- Karnofsky performance status ≥ 60 or ECOG performance status 0-2Karnofsky
- Minimum life expectancy of 3 months
- Positive CEA on immunohistology or plasma CEA ≥ 10 ng/mL
- At least one measurable lesion by CT
- At least one abnormal focus by FDG-PET
- Imaging studies must be performed within 1-4 weeks before PRAIT study to document extent of disease
- Signed informed consent form.
Exclusion
- Pregnant or lactating woman. Women of child-bearing potential will be asked to practice adequate means of birth control for a minimum of 12 months after treatment.
- Male patient refusing effective contraception for a minimum of 12 months after treatment.
- Brain metastases but patients with brain metastases controlled after treatment by Surgery or radiotherapy since more than 4 weeks are eligibles for the study. An treatment by associated corticotherapy is authorized for these patients.
- Known HIV or hepatitis
- Any serious active disease or comorbid medical condition (according to the investigator's decision and information provided in the IDB)
- Severe disorders of hemostasis or anticoagulant treatment cure
- Extensive irradiation to more than 25% of their red marrow
- Bone marrow involvement to more than 25%
- External radiation to specific organs or areas at the maximum tolerated level
- EGFR gene mutation in tumor (only for NSCLC)
- Febrile aplasia during a previous chemotherapy
- Neutrophils \< 1.5 G/l
- Platelets \< 100 G/l
- Uncontrolled diabetes
- Poor renal function (creatinine level \> 2.5 maximum normal level)
- Poor hepatic function (total bilirubin level \> 30 mmol/l, transaminases \> 2.5 maximum normal level)
- Treatment with any investigational drug within 30 days before planned PRAIT and during the study
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma,
- Presence of anti-antibody reactivity
- Known hypersensitivity to murine antibodies or proteins
- Adult patient unable to give informed consent because of intellectual impairment.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01221675
Start Date
June 1 2011
End Date
April 1 2016
Last Update
August 31 2016
Active Locations (6)
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1
CHU d'Angers
Angers, France, 49100
2
CHU
Brest, France, 29000
3
Centre Jean Perrin
Clermont-Ferrand, France
4
Hôpital La tronche
Grenoble, France, 38000