Expired Study
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Tampa, Florida 33612


Purpose:

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tretinoin may help lung cancer cells become more like normal cells and grow and spread more slowly. Giving vaccine therapy together with combination chemotherapy, with or without tretinoin, may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving vaccine therapy and combination chemotherapy together with or without tretinoin works in treating patients with extensive-stage small cell lung cancer.


Study summary:

OBJECTIVES: Primary - To determine if the combination of autologous dendritic cell-adenovirus p53 vaccine and subsequent chemotherapy (with paclitaxel after progression) will result in a substantial improvement in the clinical response in patients with extensive stage small cell lung cancer. - To determine if the addition of tretinoin to autologous dendritic cell-adenovirus p53 vaccine improves the objective tumor response rate achieved with the vaccine, by comparing the response to vaccine treatment of patients in arm II to those in arm III. - To evaluate the survival of all patients enrolled on an intent-to-treat basis, with a comparison made between the three arms. Secondary - To determine the frequency of antigen-specific T-cell responses that are induced in the patients over time, with comparisons made between treatment arms II and III. - To determine the efficacy of tretinoin in reducing the number of immature myeloid cells in patients, by comparing the numbers observed in the peripheral blood of patients in arm II as compared to arm III. OUTLINE: - Standard first-line chemotherapy: Patients receive standard first-line chemotherapy comprising carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for up to 4 courses. Patients undergo restaging after completion of first-line chemotherapy. Patients with progressive disease do not receive any protocol treatment and are changed to second-line therapy. - Adjuvant therapy: Patients with stable disease or better are then randomized to 1 of 3 arms of adjuvant therapy approximately 3 weeks after completion of first-line chemotherapy. - Arm I (Observation only [standard care]): Patients undergo observation with serial CT scans. - Arm II (Vaccine): Patients receive autologous dendritic cell-adenovirus p53 vaccine intradermally every 2 weeks for 3 doses. Patients with no sign of disease progression will undergo another leukapheresis and receive autologous dendritic cell-adenovirus p53 vaccine intradermally every 4 weeks for 3 doses. - Arm III (Vaccine and tretinoin): Patients receive autologous dendritic cell-adenovirus p53 vaccine for up to 6 doses as in arm II. They also receive oral tretinoin for 3 days before receiving each dose of the vaccine. Patients who develops evidence of disease progression at any point proceed to second-line chemotherapy with paclitaxel once every 21 days in the absence of disease progression or unacceptable toxicity. All patients undergo blood collection periodically for immunogenic analysis. After completion of study treatment, patients are followed for at least 30 days.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed extensive stage small cell lung cancer (SCLC) - No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Inclusion criteria: - ECOG performance status 0-2 - WBC > 3,000/mm³ - ANC > 1,500/mm³ - Platelets > 100,000/mm³ - Hematocrit > 25% - Bilirubin < 2.0 mg/dL - Creatinine < 2.0 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception Exclusion criteria: - Serious ongoing infection - Other pre-existing immunodeficiency condition including known HIV infection - Known pre-existing autoimmune disorder - History of a second malignancy within the past 5 years, except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Inclusion criteria: - At least 2 weeks since prior radiotherapy - At least 4 weeks since prior and no concurrent steroid therapy - No anticipated requirement for chronic steroids at the time of vaccination


NCT ID:

NCT00618891


Primary Contact:

Study Chair
Alberto Chiappori, MD
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States

Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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