Any Takers on Vaccine Clinical trial, Anyone?!

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NCI Announces New Phase I/II Study of Vaccine for NSCLC

The Metabolism Branch of the National Cancer Institute (NCI) in Bethesda, Md., has announced that it is conducting a Phase I/II clinical trial to test the efficacy of using α (1,3) galactosyltransferase expressing allogeneic tumor cells in patients with refractory or recurrent non-small cell lung cancer (NSCLC). This trial is identified as NCI-04-C-0049. Details of this trial are available at http://bethesdatrials.cancer.gov/invest ... efault.asp.

The eligibility criteria for this study include:

A diagnosis of NSCLC

Metastatic, progressive, or recurrent disease

Measurable disease

No more than one prior chemotherapy regimen (including EGFR-inhibitor therapy)

Must be able to be treated within 4 months of disease recurrence or progression

Must have a granulocyte count of ≥ 1000/mm³, lymphocyte count of ≥ 475/mm³, platelets ≥ 100,000/mm³, hemoglobin > 10.0 gm/dL, albumin ≥ 3.0 gm/dL and acceptable hepatic and renal function

Systemic corticosteroid therapy is an exclusion

Patients will be intradermally vaccinated with irradiated Alpha (1,3) galactosyltransferase-expressing lung cancer vaccine cells every 2 weeks to complete a total of eight vaccinations.

Comments: This is one of several vaccines being tested in patients with refractory NSCLC with some evidence of activity. However, there are no published data on this specific vaccine. However, vaccines do offer a relatively non-toxic approach to second line therapy.

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These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.