Vaccine trial w/ Dr. Cukos

Iam having surgery for the clinical trial 11807 at University of Penns. Do you think this is a good approach or do you think it is a waste of time?  My onc. says it wont do any good and dr cukos thinks otherwise.I have a small tumor in my upper Left peritoneal/omentum per ct (31x19mm) Left midline PI (19x9). My ca is 66.Pet/ct shows no mets. 39 y.o. active no other chemo except carb/tax/avastin(clinical trial courses 2-6 did get avastin) 7-12 did not  off trial . Thank You

[Annekathryn Goodman, M.D.]

Hi There,
Here is the link to this clinical trial:
http://clinicaltrials.gov/ct2/show/NCT00683241

I have pasted the summary below but you should also look up the link because it goes through more details. This is a phase I clinical trial.  Phase I means that the primary purpose of the trial is to evaluate the maximum toxicity of the therapy.It is not about therapeutic benefit.

However, it is a novel therapy and is scientifically interesting.I think there is no current information that this type of vaccine therapy has therapeutic benefit in ovarian cancer hence the phase I status to this trial.
best wishes


SUMMARY
Subjects with recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer, for whom autologous tumor or malignant effusion has been harvested and is available for lysate preparation, are eligible, provided all other eligibility criteria are fulfilled. Harvested tumor or malignant effusion will be shipped to Cognate BioServices (Sunnyvale, CA) for preparation of lysate. If sufficient amount of lysate for vaccine can be generated, subjects will be enrolled to the study.

Subjects will undergo apheresis on day -35 to -29 to harvest peripheral blood mononuclear cells (PBMC). The apheresis product will be shipped to Cognate BioServices, where DC will be prepared and pulsed with autologous lysate according to proprietary technology. Following apheresis, subjects will receive two cycles of biological antiangiogenesis/immunomodulatory therapy comprising intravenous bevacizumab at 10 mg/kg on day -28 and -14, which may be followed by 7 days of oral metronomic cyclophosphamide at 50 mg daily (days -28 to -21, and -14 to -7, respectively). Subjects will receive three doses of intradermal vaccination with ~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28. Subjects will also receive intravenous bevacizumab at 10 mg/kg concurrently with intradermal DCVax-L on day 0 and 14, which may be followed by oral cyclophosphamide at 50 mg for 7 days (days 0 to 7, and 14 to 21, respectively). The last DCVax-L (day 28) may be followed by oral cyclophosphamide at 50 mg daily x 7 days (days 28 to 35), but no bevacizumab will be given on day 28. Prevnar, an FDA approved seven-valent vaccine against Pneumococcus pneumoniae, will be given intramuscularly on day 0 as positive control of immune responsiveness. Two weeks following third vaccine dose (day 42), patients will undergo immune assessment.

Subjects will be contacted every 6 months for 5 years and then annually for survival. Subject will have the option of enrolling in other combinatorial immunotherapy trials when these are available, if they satisfy enrollment criteria. Subjects will have the option of continuing vaccination every two months till exhaustion of DCVax-L or disease progression, whichever occurs first.