A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer

Inclusion Criteria

• •Able to provide informed consent
• •Not on immune-modulating drugs, except those used as denileukin diftitox premedication, unless the principal investigator grants an exception (which exception must be documented in writing)
• •Histologically proven epithelial (non-germ cell, non-stromal cell) cancer of the ovaries, fallopian tubes or extraovarian peritoneal carcinoma. Clinical recurrence without documented pathology is acceptable
• •FIGO stage III or IV with failed prior first-line therapy, or ineligible for or intolerant of such therapy
• •Measurable disease as defined in section 6 within 30 days of study enrollment
• •Blood hemoglobin ≥ 8.5 gm/dl within 7 days of study enrollment
• •Absolute neutrophil count ≥ 750/mm3 within 7 days of study enrollment
• •Platelet count ≥ 40,000/mm3 within 7 days of study enrollment
• •SGOT (serum glutamic oxaloacetic transaminase) ≤10 x upper limit of normal within 7 days of study enrollment
• •Normal TSH (thyroid-stimulating hormone ) within 30 days of study enrollment
• •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 except surgery or radiation therapy to control symptoms with concurrence of the principal investigator
• •No contraindication to any study treatment
• •No active major medical problems, including untreated or uncontrolled infections
• •Beck Depression Index ≥15 within 30 days of study enrollment
• •If of reproductive potential, a negative urine pregnancy test within 3 days of study enrollment, and agreement to use adequate contraception. Pregnancy testing will continue monthly while on treatment unless the subject is no longer able to become pregnant or there is sufficient justification otherwise
• •Not breast feeding
• •Life expectancy ≥ six months
• •ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
• •Serum albumin ≥ 1.8 gm/dl
• •Age ≥ 18 years
• •Acceptable baseline retinal examination within 30 days of study enrollment
• •No active substance abuse in the prior 6 months
• •Patients failing single agent denileukin diftitox in the ongoing 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" are eligible for this trial provided that three or more weeks have elapsed since their last denileukin diftitox infusion and they meet all eligibility criteria and successfully undergo all screening examinations for this trial.