Ontak Trial

Indications studied :
This study will test the hypothesis that Ontak improves tumor immunity by killing regulatory T cells (Tregs), and will thereby treat selected patients with advanced-stage epithelial ovarian cancers.

Primary objective
•Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers

Contact Information : phone (504) 988-8840 : fax (504)988-5483

Protocol Summary

This is a non-randomized, single-arm, multicenter Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. A maximum of 60 patients will be treated with Ontak at 12 µg/kg monthly as a single one-hour infusion. Patients must have pathologic initial disease confirmation and measurable disease for study entry.

Exclusion criteria

Unable to tolerate phlebotomy.
Germ cell cancers of the ovaries, or other currently uncured cancer.
Prior or current history of autoimmune disease
Current pregnancy or breast feeding.
On immune-modulating drugs
Concurrent chemotherapy within 14 days or radiation therapy, or history of same within the thirty days prior to initiation of study treatment.
Life expectancy less than six months.
Serum albumin < 2.5 gm/dl.
Blood hemoglobin < 8.5 gm/dl.
ECOG performance status > 2.
SGOT > five times the upper limit of normal
symptomatic coronary artery disease
uncontrolled hypertension
uncontrolled, symptomatic cardiac arrhythmia
serum creatinine > 2.0 mg/dl

Inclusion criteria

No immune-modulating drugs,
No history of autoimmune disease
FIGO stage III or IV with failed prior first-line therapy, or was ineligible for or intolerant of such therapy.
Extraovarian peritoneal carcinoma
Measurable disease
Blood hemoglobin > 8.5 gm/dl.
Absolute neutrophil count > 750/mm3
Platelet count > 40,000/mm3
No chemotherapy in the 14 days prior or radiation therapy in the thirty days prior to initiation of treatment on this study.
No other concurrent chemotherapy, surgery or radiation therapy during this protocol.
No active major medical problems, including untreated or uncontrolled infections.
Not breast feeding.
Life expectancy > six months.
ECOG performance status < 2.
Serum albumin > 2.5 gm/dl.
serum creatinine < 2.0 mg/dl
SGOT < five times the upper limit of normal
Age ≥ 18 years.

Ontak Trial

A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or stage IV, or Extraovarian Peritoneal Carcinoma, Failing or Ineligible for First-Line Therapy

Indications studied : This study will test the hypothesis that Ontak improves tumor immunity by killing regulatory T cells (Tregs), and will thereby treat selected patients with advanced-stage epithelial ovarian cancers.

Primary objective •Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers

Indications studied :
This study will test the hypothesis that Ontak improves tumor immunity by killing regulatory T cells (Tregs), and will thereby treat selected patients with advanced-stage epithelial ovarian cancers.

Primary objective
•Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers