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CompletedPhase 2NCT00617409
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPaclitaxel and Drug: Ad.p53-DC vaccines

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied
Drug: Paclitaxel; Biological: Drug: Ad.p53-DC vaccines; Drug: All -trans Retinoic Acid (ATRA)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • at the time of initial registration:
  • Patients must have a histological confirmed diagnosis of Small Cell Lung Cancer (SCLC)
  • Must have extensive stage SCLC
  • Must have completed first line chemotherapy: 4-6 cycles of a standard platinum/etoposide regimen and PCI if chosen at the discretion of the treating Oncologist
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Acceptable (adequate) organ function including:
  • White blood count (WBC) \>2,500/mm³ and Absolute neutrophil count (ANC) \>1,200/mm³
  • Platelets \> 75,000/mm³
  • Hematocrit \> 24% OR Hemoglobin ≥8.5g/dl
  • Bilirubin \< 2.0 mg/dl
  • Creatinine \< 2.0 mg/dl
  • Aspartic transaminase (AST/SGOT) ≤2 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤3 x ULN
  • Patients must have achieved responsive or non-progressive disease status (stable disease \[SD\], partial response \[PR\], or complete response \[CR\]) assessed 4-6 weeks after the last cycle of first line chemotherapy. SD, PR or CR may be confirmed after completion of prophylactic cranial irradiation (PCI) at the discretion of the principal investigator (PI) after discussion with the treating oncologist.
  • 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.
  • Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study
Reasons someone may not be able to joinExclusion criteria
  • at the time of initial registration:
  • Patients with severe, uncontrolled intercurrent illness or infection
  • Anticipated requirement for systemic chronic steroid use at the time of vaccination, unless specifically indicated for dose supplementation or replacement of established corticosteroid insufficiency
  • Receiving systemic doses of corticosteroids should have them discontinued ≥ 2 weeks prior to starting vaccination (this include patients receiving steroids with PCI). Inhaled steroids should also be discontinued if at all possible. Chronic, stable doses of inhaled steroids for the treatment of chronic obstructive pulmonary disease (COPD), etc. are allowed if in the opinion of the treating physician(s) they cannot be stopped.
  • Any pre-existing immunodeficiency condition, or a known history of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
  • Uncontrolled and/or symptomatic central nervous system (CNS) metastasis
  • Pregnant or lactating women. A pregnancy test-serum Beta human chorionic gonadotropin (bHCG) will be obtained during the screening process.
  • Have received any chemotherapy other than the first line chemotherapy specified in the study protocol: standard platinum/etoposide regimen
  • 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 3 years. Exceptions include: non-melanoma skin cancers, any in-situ carcinomas and successfully treated early stage malignancies without evidence of recurrence for \> 18 months.
  • Have not recovered from any chemotherapy-related or other therapy-related toxicity at study entry
  • Have had major surgery without full recovery or major surgery within 3 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 Pre-Pheresis Criteria:
  • Patients must have had a successful harvest of peripheral blood mononuclear cell (PBMC) with leukopheresis at least 6-10 weeks after chemotherapy.
  • ECOG performance status of 0-2
  • The last dose of first line chemotherapy must have been administered at least 4 weeks prior to the first vaccine administration.
  • Patients who received radiation therapy: last dose of radiation must have been completed at least 2 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)
  • Patients who received steroid therapy: last steroid dose must have been given at least 2 weeks prior to the first vaccine administration
  • Adequate organ function:
  • WBC \> 2,500/mm³ and ANC \>1,200/mm³
  • Platelets \> 75,000/mm³
  • Hematocrit \> 25%
  • Hemoglobin ≥9g/dl
  • Bilirubin \< 2.0 mg/dl
  • Creatinine \< 2.0 mg/dL
  • AST/SGOT ≤ 2 x ULN
  • 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 Pre-Paclitaxel Eligibility:
  • Progressive disease after observation (Arm A) or vaccinations (Arms B and C)
  • ECOG performance status of 0-2
  • Adequate organ function:
  • WBC \> 2,500/mm³ and ANC \>1,200/mm³
  • Platelets \> 75,000/mm³
  • Hematocrit \> 25%
  • Hemoglobin ≥9g/dl
  • Bilirubin \< 2.0 mg/dl
  • Creatinine \< 2.0 mg/dL
  • AST/SGOT ≤ 2 x ULN
  • Alkaline phosphatase \< 3 x ULN

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 8, 2019. Always confirm current availability with the study team.

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