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

Phase 2

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Paclitaxel; Drug: All -trans Retinoic Acid (ATRA)

• Registration Number: NCT00617409
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of this research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking and/or the amount of time that people who have this disease will live.

Detailed Description

After initial diagnosis patients will be treated with a standard platinum/etoposide regimen. This standard first-line chemotherapy may/will be administered to patients under the direction of their primary medical oncologist inside or outside of the Moffitt Cancer Center. Patients will receive the platinum drug on day 1 and etoposide on days 1-3 of each 21-day cycle for 4-6 cycles. Patients who have progressive disease (PD) at this point are changed to second line chemotherapy, and will not be eligible to participate in this clinical trial. Patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) after standard first-line chemotherapy will be enrolled. Radiographic studies and tumor measurements are repeated 3-6 weeks after the last dose of chemotherapy (+/- PCI) and may be repeated after prophylactic cranial irradiation (PCI) at the discretion of the principal investigator (PI) and treating physician.

PCI will be permitted at the discretion of the treating oncologist(s). The initial radiation consultation and simulation should occur as soon as the final staging has occurred. Ideally, treatment should commence 1-2 weeks after final staging has been confirmed and will be administered in 10-15 fractions over a 2-3 week period, as recommended by the treating radiation oncologist. Although steroid use is not prohibited, it is recommended and preferred that they not be used during PCI (steroids will have to be discontinued ≥ 2 weeks before first vaccination). PCI can also be considered between vaccines #4 and #5 or vaccine #5 and #6 in those patients eligible for the second course of vaccinations. Systemic dose of steroids will NOT be allowed in these cases unless strictly necessary and after discussion with the PI.

Patients who achieve CR, PR or SD after the completion of first line chemotherapy +/- PCI will be screened for initial registration. Screening tests and procedures will be performed approximately 4-6 weeks after the completion of first line chemotherapy or 6-9 weeks after completion of PCI. Ideally, screening should be completed 1-2 weeks prior to leukopheresis.

Patients who successfully complete the screening exams for initial registration will be randomized into one of three study arms.

Study Timeline

• Study Start: 2007-10-02
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-18
• Primary Completion: 2015-09-21
• Results First Submitted: 2016-09-12
• Results First Submitted QC: 2016-09-12
• Results First Posted: 2016-11-01
• Study Completion: 2019-01-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ad.p53-DC Vaccines + ATRA	All -trans Retinoic Acid (ATRA)	Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemotherapy
Standard of Care	Paclitaxel	Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
Ad.p53-DC Vaccines + ATRA	Paclitaxel	Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemotherapy
Ad.p53-DC Vaccines	Paclitaxel	Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate (RR)	12 months	Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 24 months	To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States