A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine for Recurrent Ovarian or Primary Peritoneal Cancer

Completed · Phase 1

Conditions studied: Ovarian Cancer, Peritoneal Cancer

In brief

This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion in order to make the first part of the vaccine or lysate. If enough of the lystate had been collected to make the first part of the vaccine, then subjects may enroll in the study as long as they meet the rest of the entry criteria. After is determined that a subject is eligible to enroll into the study, you will have to donate some blood in order to make the second part of the vaccine. After this, the blood and vaccine are mixed together to make the vaccine called DCVax-L. You will be given two dose of a drug called Avastin every other week (Avastin will be given through your vein) and a oral chemotherapy called Cytoxan. One week after your last dose of oral Cytoxan, you will receive 3 vaccines given every other week for the next month. After the first two doses of vaccine, you will also receive more Avastin. During the study you will be seeing your study team to have physical exams, blood drawn in order to monitor your health and have blood drawn for research. The study team will contact you for the next 5 years in order to determine how you are doing.

Key facts

Study ID

NCT00683241

Run by

Abramson Cancer Center at Penn Medicine

People needed

36

Starts

2007-11-01

Expected to finish

2009-12-01

Last updated by the study team

2013-02-26

Who can join

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

You may qualify if…

• Recurrent stage II to IV ovarian carcinoma or primary peritoneal carcinoma.
• Subjects with prior secondary cytoreductive surgery or aspiration of malignant effusion yielding tumor for lysate preparation.
• Subjects must have sufficient lysate for DCVax-L preparation (> 10 mg of pure protein lysate from tumor, ascites or malignant pleural effusion cell preparation).
• largest tumor nodule ≤ 2.5 cm
• Patients who have achieved complete response following surgery and chemotherapy are still eligible for vaccine.
• may be platinum-sensitive or platinum-resistant
• may have received chemotherapy or other therapy after harvest of tumor
• must have recovered from toxicities of prior chemotherapy or other therapy.
• completed all parenteral investigational therapy 14 days and have completed all oral investigational therapy 7 days prior to enrollment
• must have completed all hormonal therapy 7 days prior to enrollment.
• must have recovered from toxicities of radiation therapy (to grade 2 or less).
• at least 4 weeks postoperative recovery
• coagulation studies w/i normal limits
• ECOG > 2
• Life expectancy of > 4 months.
• must understand and sign the study specific informed consent.

You may not qualify if…

• not enough lysate for vaccine preparation
• known brain metastases
• any of the following positive tests at the screening visit: (HTLV-1/2 ; Hepatitis B, HIV, Hepatitis C, Anti-Yo(cdr2) antibody present in serum
• on corticosteroids
• prior IV Cytoxan at maximally tolerated dose
• serum creatinine > 2.2 mg/dl or BUN > 40 mg/dl
• proteinuria > 3.5gm over 24 hrs
• serum total bilirubin > 2.0 and/or serum transaminases > 3X the upper limits of normal
• Platelets < 100,000/ mm3 ; WBC < 3,000/mm3 ; Absolute Neutrophil Count (ANC) < 1,500/mm3 ; Absolute lymphocyte count < 1000/ mm3 ; Hematocrit < 30%
• acute infection that requires specific therapy
• serious, non-healing wound, ulcer, or bone fracture
• active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
• history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
• clinically significant cardiovascular disease; this includes: (Uncontrolled hypertension ; Myocardial infarction or unstable angina within 6 months prior to registration ; New York Heart Association (NYHA) Grade II or greater congestive heart failure ; Serious cardiac arrhythmia requiring medication ; Grade II or greater peripheral vascular disease.
• clinically significant peripheral artery disease, e.g., those with claudication, within 6 months.
• clinical symptoms or signs of partial or complete gastrointestinal obstruction or who require parenteral hydration and/or nutrition.
• any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study). Subjects with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
• organ allografts.
• known autoimmune/collagen vascular disorder.
• on any medications that might affect immune function. Additionally, H2 antagonists are excluded as are all antihistamines five days before and five days after each injection of study drug. NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are exceptions.
• pregnant or lactating.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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