Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer

Condition(s) targeted: Lung Cancer

Intervention: Vaccine Treatment (Biological); Cyclophosphamide (Drug); All-trans retinoic acid (ATRA) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

Official(s) and/or principal investigator(s):
Alberto Chiappori, MD, Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

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.

Official title: Combination Immunotherapy for Lung Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Evaluable Participants With Tumor Response

Secondary outcome:

Median Time to Progression (TTP)

Median Overall Survival (OS)

Number of Participants With Serious Adverse Events (SAEs)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2006
Last updated: May 15, 2013