Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

Stopped early · Phase 2

Conditions studied: Epithelial Ovarian Cancer, Peritoneal Neoplasms, Fallopian Tube Neoplasms

In brief

Background: \- Birinapant is an experimental cancer treatment drug. It removes certain proteins in cells, which helps to kill the cells. The drug is more likely to cause the death of cancer cells than normal cells because cancer cells have more of these proteins. Studies suggest that it can help treat ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Researchers want to see how well Birinapant works against the three types of cancer. Objectives: \- To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube cancer. Eligibility: \- Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube cancer that has not responded to standard treatment. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected before treatment. Imaging studies will also be performed. * Participants will have an infusion of Birinapant once per week for 3 weeks in a row, followed by a break for a week on the fourth week. This 4-week schedule is one cycle of treatment. * Treatment will be monitored with frequent blood tests and imaging studies. * Another optional tumor biopsy will be collected 6 weeks after the start of treatment. * Treatment will continue as long as the cancer does not grow and the side effects are not severe.

Key facts

Study ID

NCT01681368

Run by

National Cancer Institute (NCI)

People needed

11

Starts

2012-08-15

Expected to finish

2014-04-30

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Known or suspected diagnosis of human immunodeficiency virus or chronic active hepatitis B or C. Viral testing is not required. The reason for exclusion is insufficient evidence demonstrating safety of administration of birinapant in patients with human immunodeficiency virus (HIV), hepatitis B or C due to theoretical risk of unmasking or exacerbating these serious viral illnesses since birinapant may impair immunological function. Data are not currently available on risk of interaction with antiretroviral drugs. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with birinapant. The potential immune suppressive effects and T-cell depletion associated with birinapant pose an additional increased risk to these patients. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
• Symptomatic or uncontrolled brain metastases requiring current treatment (< 8 weeks from last cranial radiation or < 4 weeks from last steroids). (Patients with abnormal clinical exam or history will require a head CT or MRI to rule out or confirm brain metastases).
• Impaired cardiac function or clinically significant cardiac disease including the following:
• New York Heart Association grade III or IV congestive heart failure.
• Myocardial infarction within the last 12 months prior to dosing with birinapant.
• Subjects known to have impaired left ventricular ejection fraction (LVEF) according to institutional standards must be excluded.
• Lack of recovery of prior adverse events to Grade less than or equal to1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 4.03) (except alopecia) due to therapy administered prior to the initiation of study drug dosing. Stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the Investigator as birinapant has not been shown to cause or exacerbate peripheral neuropathy.
• Known allergy to any of the formulation components of birinapant including citric acid monohydrate, sodium citrate dehydrate, and sodium chloride.
• Any concurrent disease and/or medical condition that in the opinion of the Investigator would prevent the subjects participation, render the subject at excessive risk or limit the subjects compliance with the protocols required evaluations.
• Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics.
• Another previous or current malignancy within the last 5 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ curatively treated, ductal or lobular carcinoma in situ curatively treated and without ongoing therapeutic intervention. Patients with breast cancer (BRCA) 1 or 2 mutation, who have had a previous diagnosis of breast cancer are eligible if the breast cancer was diagnosed 5 years previously and distant or local recurrence of breast cancer has been outruled.
• Concomitant chronic (daily or almost daily for greater than or equal to1 month prior) use of steroids or non-steroidal anti-inflammatory drugs (NSAIDS). Intermittent use of steroids as pre-medications is allowed. Based on research to date the tumor and tumor microenvironment production of tumor necrosis factor (TNF) alpha could promote anti-tumor activity. Theoretically, anti-inflammatories could blunt local production, limiting this possibly positive cofactor.
• No concomitant use of complementary or alternative medication or other agents (investigational therapeutic agents) will be allowed without approval of a principal investigator (PI) or associate investigator (AI). Every effort will be made to maximize patient safety and minimize changes in chronic medications.
• Patients with a recent history (within last 5 years) of autoimmune disease or inflammatory diseases will be excluded, for example, active rheumatoid arthritis,active inflammatory bowel disease or any chronic inflammatory conditions because birinapant synergizes with TNF in vitro.
• INCLUSION OF MINORITIES:
• Women from all racial/ethnic groups are eligible for this study if they meet the eligibility criteria.
• To date, there is no information that suggests that differences in drug metabolism or disease response would be expected in one group compared to another. Efforts will be made to extend accrual to a representative population, but in this preliminary study, a balance must be struck between patient safety considerations and limitations on the number of individuals exposed to potentially toxic and/or ineffective treatments on the one hand and the need to explore ethnic aspects of clinical research on the other hand. If differences in outcome that correlate to ethnic identity are noted, accrual may be expanded or a follow-up study may be written to investigate those differences more fully. This study will be recruited through internal referral, our local physician referral base, and through Cancer Hotline information.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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