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

NCT00683241 | Completed Phase 1

• 1 other identifier: UPCC 11807
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer; Peritoneal Cancer

Keywords

Vaccine; Ovarian; Peritoneal

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility and safety of administering DCVax-L intradermally combined with intravenous bevacizumab and oral metronomic cyclophosphamide in patients with recurrent ovarian or primary peritoneal cancer.

  2 years

Secondary Outcomes (1)

• To assess the immunogenicity of DCVax-L administered intradermally in patients with recurrent ovarian or recurrent primary peritoneal cancer, combined with intravenous bevacizumab and oral metronomic cyclophosphamide.

  2 years

Study Arms (1)

1

EXPERIMENTAL

Subjects with stage II to IV recurrent epithelial ovarian carcinoma or recurrent primary peritoneal cancer, from whom solid tumor, ascites or pleural effusion will be harvested and available and sufficient for lysate preparation; and whose largest tumor nodule is ≤ 2.5 cm. Subjects may have undergone chemotherapy or other therapy following tumor harvesting and prior to enrollment (apheresis).

Biological: DCVac-L

Interventions

DCVac-L BIOLOGICAL

Subjects will receive three doses of intradermal vaccination with \~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Northwest Biotherapeutics: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Gynecologic Oncology @ University of Pennsylvania

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• George Coukos, M.D., Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 23, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

US (1)