TF2- Small Cell Lung Cancer Radio Immunotherapy
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 the current recommended regimens are falling short. In addition, many of the commonly used chemotherapy agents are associated with severe nonhematologic toxicities that are often cumulative and nonreversible and impair quality of life in this essentially palliative setting. Therefore, agents with novel mechanisms of action and superior safety profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic antigen (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The investigators group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb) can deliver a higher radiation dose to a tumor than a directly radiolabeled anti-CEA antibody, and shows improved anti-tumor efficacy. This clinical trial is designed to assess PRAIT using an entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the treatment of CEA-expressing small cell lung cancers (SCLC).
Small Cell Lung Cancer
Drug: Antibody TF2
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Multicentric Optimization and Phase I/II Study of Pretargeted Radioimmunotherapy (PRAIT) Using Anti-CEA x Anti-HSG TF2 Bispecific Antibody (bsMAb) and 177Lu-IMP-288 Peptide in Patients With CEA-expressing Small Cell Lung Carcinoma (SCLC)|
- Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288. [ Designated as safety issue: Yes ]
- Primary endpoint of study plan II • the maximum tolerated dose (MTD) for the TF2-pretargeted 177Lu-IMP-288 under optimal pretargeting conditions. [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Drug: Antibody TF2
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 anti-HSG bsMAb TF2 and the 177Lu-IMP-288 peptide pretargeted in patients with CEA-positive SCLC.
This study has 2 parts: Study plan I (Optimization study) and Study plan II (Escalating activity phase I/II study).
The Study plan I is designed to optimize the pretargeting procedure using blood pharmacokinetics (Pk) and dosimetry in 9 patients receiving escalating doses of TF2 followed 2 to 4 days later by 1.1 GBq/m2 of 177Lu-IMP-288.
The study plan II is designed to determined MTD of 177Lu-IMP-288 using dosimetry and toxicity data in a phase I/II study performed in patients receiving optimal dose of TF2 bsMAb (determined in study plan I) followed 2 to 4 days by escalating activity of 177Lu-IMP-288.
A pre-therapy imaging study (using TF2 followed 2 to 4 days later by 185 MBq of 111In-IMP-288) is performed in the two study plans to qualify a patient for treatment with the subsequent therapy dose.
|CHU||Not yet recruiting|
|Brest, France, 29000|
|Contact: Pierre Yves Salaün, MD email@example.com|
|Hôpital La tronche||Not yet recruiting|
|Grenoble, France, 38000|
|Contact: Jean Philippe Vuillez, MD JPVuillez@chu-grenoble.fr|
|Nantes, France, 44093|
|Contact: Françoise Bodere, MD françoise.firstname.lastname@example.org|
|Centre Eugène Marquis||Not yet recruiting|
|Rennes, France, 35000|
|Contact: Etienne Garin, MD email@example.com|
|Centre René Gauducheau||Recruiting|
|Saint Herblain, France, 44805|
|Contact: Françoise Bodere, MD +33240679900|
|CHU Rangueil||Not yet recruiting|
|Toulouse, France, 31000|
|Contact: Fréderic Courbon, MD Courbon.Frederic@claudiusregaud.fr|