Clinical trial NCT00601796: Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
Official title: Combination Immunotherapy for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: adenocarcinoma of the lung
stage IV non-small cell lung cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2008-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.

Detailed description: This protocol describes a phase II study involving patients with stage IV adenocarcinoma of the lung. Treatment will consist of Cyclophosphamide (300 mg/m²) to be given IV on day 1 and day 57. On day 4 immunization with intradermal vaccine injections at 4 separate sites (bilateral upper arms and bilateral upper thighs will be repeated every 14 days times 2 followed by every 28 days times 3 (day 4, 18, 32, 60, 88, and 116). Decavac (tetanus shot) 0.5 cc intramuscular (IM) will be given after the first vaccine. ATRA (150 mg/m2/day) oral three times daily (TID) dosing administered after the first and fourth vaccines (day 5-7 \& day 61-63). Those patients achieving stable disease (SD), partial response (PR), or complete response (CR) at restaging after the initial 6 vaccines will receive additional vaccines every 3 months until disease progression. The vaccine will consist of GM.CD40L bystander cells admixed with an equivalent number of the 2 allogeneic tumor cell lines. There will be a +/- 7 day window for all study related exams, tests, and procedures.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the lung
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
* No radiation therapy within 2 weeks of first vaccine administration
* No chemotherapy within 4 weeks of first vaccine administration
* No steroid therapy within 4 weeks of first vaccine administration
* Patient's written informed consent
* Adequate organ function (measured within a week of beginning treatment)
* Patients will be tested for human leukocyte antigen A0201 (HLA-A0201) as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen, however this result will not be an inclusion criterion.
* Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter greater than or equal 20mm. With spiral computer tomography (CT) scan, lesion must be greater than or equal to 10 mm at least one dimension.
* Patient's must have received, and completed first line chemotherapy.

Exclusion Criteria:

* Symptomatic brain metastasis
* Any acute medical problems requiring active intervention
* Current corticosteroid (other than replacement doses in patients who are hypoadrenal) or other immunosuppressive therapy
* Any other pre-existing immunodeficiency condition (including known HIV infection)
* Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment).
* Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3 or 4

Primary outcomes:
measure: Number of Evaluable Participants With Tumor Response
timeFrame: 3 years
Secondary outcomes:
measure: Median Time to Progression (TTP)
timeFrame: 3 years
measure: Median Overall Survival (OS)
timeFrame: 3 years
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 3 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Alberto Chiappori, MD
role: PRINCIPAL_INVESTIGATOR
References: