| Abstract | BACKGROUND: SRL172 is a suspension of heat killed Mycobacterium vaccae, that has been found to be a potent immunological adjuvant when used with autologous cells in animal models. This is a phase II study to test the clinical activity, feasibility and safety of combining SRL172 with chemotherapy to treat patients with small cell lung cancer (SCLC). METHODS: Patients were randomized to receive chemotherapy with (n=14) or without (n=14) SRL172. The chemotherapy was either platinum-based (MVP, n=10) or anthracycline-based (ACE, n=18). SRL172 was given intradermally on day 0, weeks 4, 8 and then 3-6 monthly. RESULTS: The treatment arms were well balanced for disease extent (43% with limited stage in each arm). The toxicity of chemotherapy and overall response at 12-15 weeks (57%) was the same for both treatment regimens. Median survival was 8.6 months and 12.9 for patients treated with chemotherapy alone and with the combination respectively (P=0.10). The survival trend was similar for both disease extent and chemotherapy regimen employed in favour of combination chemotherapy with SRL172. CONCLUSIONS: There is a trend to improved median survival in SCLC with the combination of chemotherapy and SRL172 with no increased toxicity and irrespective of drug regimen. A phase III study examining chemotherapy in combination with SRL172 in SCLC is now underway. |
| Authors | L Assersohn, B E Souberbielle, M E R O'Brien, C D Archer, R Mendes, R Bass, K V Bromelow, R D Palmer, E Bouilloux, D A Kennard, I E Smith
(Affiliation: Royal Marsden Hospital NHS Trust, Sutton, Surrey, UK.)
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| Journal | Clinical oncology (Royal College of Radiologists (Great Britain))
(Clin Oncol (R Coll Radiol))
Vol. 14
Issue 1
Pg. 23-7
(Feb 2002)
ISSN: 0936-6555 England |
| PMID | 11899903
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
- Bacterial Vaccines
- SRL172
|
| Topics |
- Aged
- Bacterial Vaccines
(therapeutic use)
- Carcinoma, Small Cell
(drug therapy)
- Feasibility Studies
- Female
- Humans
- Lung Neoplasms
(drug therapy)
- Male
- Middle Aged
- Mycobacterium
- Pilot Projects
|
