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A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Safety Issue:

No

Principal Investigator

Alberto Chiappori, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

Unspecified

Study ID:

CDR0000581160

NCT ID:

NCT00618891

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612