Recurrent Ovarian Carcinoma Clinical Trial
Official title:
Treatment of High Risk or Recurrent Ovarian Cancer With Anti-CD3 x Anti-HER2 Bispecific Antibody Armed Activated T Cells (BATs), Low Dose IL-2, and GM-CSF (Phase I).
This phase I trial studies the side effects and best dose of activated T-cell therapy when given together with low-dose aldesleukin and sargramostim in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is stage III-IV, has not responded to previous treatment, or has come back. Activated T cells that have been coated with bi-specific antibodies, such as anti-cluster of differentiation (CD)3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Giving activated T-cell therapy with low-dose aldesleukin and sargramostim may be a better treatment for ovarian, fallopian tube, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
I. Perform a phase I clinical trial consisting of dose-escalation/de-escalation of
intraperitoneal (IP) infusions of anti-CD3 x anti-HER2/neu (HER2Bi) armed anti-CD3 activated
T cells (aATC) in women with high risk or recurrent ovarian cancer to determine the maximum
tolerated dose (MTD) for IP injections in combination with a fixed intravenous (IV) dose of
10 x 10^9 (± 20%) aATC once a week.
II. To clearly define the toxicity profile of IP and IV HER2Bi aATC at the MTD or
technically feasible dose in patients with ovarian cancer.
SECONDARY OBJECTIVES:
I. Evaluate clinical responses, time to progression, and overall survival. II. Evaluate
phenotype, cytokine profiles and interferon (IFN)-gamma enzyme-linked immunosorbent spots
(ELISPOTS), cytotoxicity and antibodies directed at laboratory ovarian cancer cell lines.
III. Monitor cancer antigen (CA)125 or tumor markers, and antibody responses to mouse
proteins (human anti-mouse antibodies [HAMA]).
IV. The migration of armed ATC out of the peritoneal and serum cytokine levels induced by IP
or IV armed ATC infusion will be assessed by studying the appearance of armed ATC at various
time points (0, 4, 8, 12, 24, 48, 72, and 96 hours after IP infusion) in the blood after IP
infusions by performing flow cytometry to detect anti-CD3 (OKT3) x anti-Her2 (Herceptin®)
bi-specific antibody (BiAb) on the surface of aATC.
OUTLINE: This is a dose-escalation study of IP infused HER2Bi-armed activated T cells.
Patients receive HER2Bi-aATC IV over 5-15 minutes and IP within 3-4 days of IV dose weekly
for 4 weeks. Patients also receive low-dose aldesleukin subcutaneously (SC) daily and
sargramostim SC twice weekly beginning 3 days before the first HER2Bi-aATC infusions
infusion and ending 7 days after the last HER2Bi-aATC infusion. Treatment continues in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 3 months, and then
every 6 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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