Full Text View
Tabular View
No Study Results Posted
Related Studies
To Immunize Pts w Extensive Stage SCLC Combined w Chemo w or w/oAll Trans Retinoic Acid
This study is ongoing, but not recruiting participants.
First Received: February 5, 2008   Last Updated: January 30, 2009   History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
Introgen Therapeutics
Information provided by: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00617409
  Purpose

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 amount of time that people who have this disease will live. The vaccine will be made by inserting a gene (p53 gene) into a subset of the patient's own white blood cells. The vaccine will be given after the patient receives standard first-line chemotherapy, and may be given after second-line chemotherapy. One third of the people involved in the study will also be given a medication called All Trans Retinoic Acid (ATRA).


Condition Intervention Phase
Small Cell Lung Cancer
Other: Observation
Biological: Drug: Ad.p53-DC vaccines
Drug: Ad.p53-DC vaccines + ATRA
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Tretinoin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • To evaluate the efficacy of the combination of the Ad.p53-DC vaccine, with (Arm C) and without (Arm B) ATRA, and subsequent chemotherapy (paclitaxel). That is, to estimate the objective tumor response rate for each treatment group. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the survival of all patients enrolled on an intent-to-treat basis, with a comparison made between the 3 arms. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 81
Study Start Date: October 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Observation until evidence of progressive disease (standard of care)
Other: Observation
Group A - Observation, standard of care. All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads.
B: Experimental
Ad.p53-DC vaccines
Biological: Drug: Ad.p53-DC vaccines
Group B - Leukopheresis, vaccines x 3, rescan if stable repeat leukopheresis + three more vaccines. All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads.
C: Experimental
Ad.p53-DC vaccines in combination with ATRA
Drug: Ad.p53-DC vaccines + ATRA
Group C - Leukopheresis, ATRA pills with vaccine x 3, re-scan, stable-repeat leukopheresis plus ATRA pills with vaccine x 3-Rescan. All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria at the time of initial registration:

  • Must have a histologically confirmed diagnosis of SCLC.
  • Must have extensive stage SCLC and/or lesions that have spread to other tissues in the chest or other parts of the body.
  • Must have completed first line chemotherapy: 4-6 cycles of a standard platinum/etoposide regimen.
  • ECOG performance status of 0-2.
  • Adequate organ function including:

    1. WBC > 3,000/mm³ and ANC > 1500/ mm³
    2. Platelets > 100,000/ mm³
    3. Hematocrit > 25%
    4. Hemoglobin ≥10g/dl
    5. Bilirubin < 2.0 mg/dl
    6. Creatinine < 2.0 mg/dl
    7. AST/SGOT ≤2 x ULN
    8. Alkaline phosphatase ≤3 x ULN
  • Tumor Assessment: SD, PR, or CR assessed 3 weeks after the last cycle of first line chemotherapy
  • Males and Females of reproductive potential must agree to use effective contraception during the study and for at least 4 weeks after the last dose of ATRA. Patients are instructed and agree to notify the principal investigator should a pregnancy occur for themselves or their partner.
  • Must be willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study.

Inclusion Criteria just prior to treatment with vaccines:

  • Must have had a successful harvest of PBMC with leukapheresis at least 6 weeks after chemotherapy.
  • ECOG performance status must be 0-2.
  • The last dose of first line chemotherapy must have been administered at least 4 weeks prior to the first vaccine administration.
  • For patients who received radiation therapy, the last dose of radiation must have been completed at least 4 weeks prior to the first vaccine administration and the patient must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia).
  • For patients who received steroid therapy, the last steroid dose must have been given at least 4 weeks prior to the first vaccine administration
  • Adequate organ function:

    1. WBC > 3,000/mm³ and ANC > 1500/ mm³
    2. Platelets > 100,000/ mm³
    3. Hematocrit > 25%
    4. Hemoglobin ≥10g/dl
    5. Bilirubin < 2.0 mg/dl
    6. Creatinine < 2.0 mg/dl
    7. AST/SGOT ≤ 2 x ULN
    8. Alkaline phosphatase < 3 x ULN
  • Patients must have signed informed consent at initial registration.
  • HLA-A*0201 Testing as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen, however this result will not be an inclusion criterion

Exclusion Criteria at the time of initial registration:

  • Severe, uncontrolled intercurrent illness or infection.
  • Anticipated requirement for chronic steroid use at the time of vaccination.
  • Any pre-existing immunodeficiency condition, or a known history of HIV, Hepatitis B or Hepatitis C.
  • Uncontrolled CNS metastasis will not be permitted.
  • Pregnant or lactating women. A pregnancy test-serum BHCG will be obtained during the screening process.
  • Patients who have received any chemotherapy other than the first line chemotherapy specified in the study protocol: standard platinum/etoposide regimen.
  • Patients who have received any prior investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy for treatment of SCLC.
  • Any known pre-existing autoimmune disorder.
  • History of a second malignancy within the previous 5 years (except non-melanoma skin cancer and cervical in-situ).
  • Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity at study entry.
  • Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment.
  • Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study

Exclusion Criteria for vaccine registration:

  • Uncontrolled brain metastasis.
  • Ongoing steroid use or the anticipated requirement for steroid use during the treatment period.
  • ECOG performance status of 3 or 4.
  • Any serious ongoing infection.
  • Patients who have had major surgery within 3 weeks of the start of vaccine treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617409

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Introgen Therapeutics
Investigators
Principal Investigator: Alberto Chiappori, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute ( Alberto Chippori, M.D. )
Study ID Numbers: MCC-15206, IND#9792, USFIRB#105790, IBC#0147NE, OBA 0705-857, INT 225-004
Study First Received: February 5, 2008
Last Updated: January 30, 2009
ClinicalTrials.gov Identifier: NCT00617409     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
SCLC

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Keratolytic Agents
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Tretinoin
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Keratolytic Agents
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Tretinoin
Adenocarcinoma
Dermatologic Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009