Phase 2
Completed N=69
To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid
Source: ClinicalTrials.gov NCT00617409 ↗Enrolled (actual)
69
Serious AEs
40.6%
Results posted
Nov 2016
Primary outcomePrimary: Tumor Response Rate (RR) — 8; 6; 12; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response Rate (RR) |
8; 6; 12; 1; 5; 6 | — |
| SECONDARY Overall Survival (OS) |
12.17; 6.32; 6.20 | — |
Eligibility Criteria
Inclusion 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 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 2,500/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
Data sourced from ClinicalTrials.gov (NCT00617409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.