A Randomized Pilot Phase II Study of Docetaxel Alone or in Combination With PANVAC(Trademark)-V (Vaccinia) and PANVAC(Trademark)-F (Fowlpox) in Adults With Metastatic Breast Cancer
Background:
Weekly docetaxel therapy is currently used as a standard treatment for patients with
metastatic breast cancer.
Although many patients initially respond to this form of therapy, the majority will
eventually develop disease progression and die from their disease.
We have explored the use of combining pox vector vaccines with docetaxel. In a recent
clinical trial, men with prostate cancer were given both the vaccine and docetaxel without
any significant toxicity and the docetaxel did not diminish immune responses to the vaccine.
Objectives:
To evaluate progression free survival comparing PANVAC + docetaxel vs. docetaxel alone in
patients with metastatic breast cancer.
To evaluate overall survival comparing PANVAC + docetaxel vs. docetaxel alone in patients
with metastatic breast cancer.
To evaluate in both arms cluster of differentiation 8 (CD8+) T cell responses directed
against carcinoembryonic antigen (CEA) and mucin (MUC-1) in human leukocyte antigen 2
(HLA-A2), A3, and A24 positive patients by interferon-gamma enzyme linked immunosorbent spot
(ELISPOT) assay.
Eligibility:
Metastatic breast cancer (either male or female) with evidence of metastatic disease (must
have radiographic evidence of disease) and life expectancy of at least 4 months.
Patients may have received unlimited prior hormonal therapy or chemotherapy, but no prior
docetaxel for metastatic disease.
Hematological eligibility parameters within 16 days of starting therapy:
Granulocyte count greater than or equal to 1,500/mm^3, Platelet count greater than or equal
to 100,000/mm^3, hemoglobin (Hgb) greater than or equal to 8 Gm/dL.
Design:
A randomized Phase II study evaluating the role of combining docetaxel with PANVAC[TM]-V
(recombinant vaccinia containing the genes encoding for CEA, MUC-1, lymphocyte
function-associated antigen 3 (LFA-3), intercellular adhesion molecule 1 (ICAM-1) and B7.1)
and PANVAC[TM]-F (recombinant fowlpox containing the genes encoding for CEA, MUC-1, LFA-3,
ICAM-1 and B7.1) vs. docetaxel alone to determine if the addition of the vaccine can prolong
the time to disease progression as well as overall survival in patients with metastatic
breast cancer.
Patients randomized to docetaxel alone may receive sequential therapy with PANVAC[TM]-V and
PANVAC[TM]-F at time of disease progression.
In patients randomized to the concurrent therapy, PANVAC[TM]-V will be administered to
patients 3 weeks prior to the start of chemotherapy as the initial vaccine.
The immune responses to CEA and MUC-1 will then be boosted by administration of
PANVAC[TM]-F.
Sargramostim or granulocyte macrophage colony stimulating factor (GM-CSF) will be
administered with each vaccine inoculation for four consecutive days only for patients
treated at the National cancer Institute (NCI).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS)
Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.
19.7 months
No
James L Gulley, M.D., Ph.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
050229
NCT00179309
September 2005
May 2014
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |