To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

October 2, 2007

Primary Completion Date

September 21, 2015

Study Completion Date

January 31, 2019

Conditions
Small Cell Lung Cancer
Interventions
DRUG

Paclitaxel

All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads. At any point when a patient develops evidence of progressive disease, the patient will be treated with second-line chemotherapy. Paclitaxel will be given at a dose of 200 mg/m² on day 1 of 21 day cycles.

BIOLOGICAL

Drug: Ad.p53-DC vaccines

Patients randomized to Arm B will receive vaccinations on 3 occasions, at 2 week intervals. 1-5x106 p53 positive DCs in 1 ml will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2-3 weeks after vaccine # 3 (first vaccine course). If patients show no sign of disease progression at restaging, then a second leukopheresis will be performed. Patients will then be vaccinated 3 more times (second vaccine course) at 4-week intervals, for a total of 6 possible vaccines. Restaging will occur 2-4 weeks after completing the second vaccine course. Patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).

DRUG

All -trans Retinoic Acid (ATRA)

The patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00617409 - To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid | Biotech Hunter | Biotech Hunter