Autologous OC-DC Vaccine in Ovarian Cancer

NCT01132014 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: UPCC 19809
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.

Conditions

Chemotherapy; Tumor; Ovarian Cancer

Keywords

Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer,; from whom solid tumor or ascites have been harvested and are available and; sufficient for tumorlysate preparation;and whose largest tumor nodule is 4.5; cm. Subjects may have undergone chemotherapy or other therapy following; tumor harvesting and prior to enrollment.

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.

  30 days of last vaccination

Secondary Outcomes (3)

• Clinical Response

• Dose limiting toxicity

• Immune Response Immune Response

Interventions

OCDC BIOLOGICAL

OCDC,an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab.

Eligibility Criteria

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

You may qualify if:

• Subject has had prior cytoreductive surgery yielding tumor for lysate preparation.
• Lysate must meet release criteria
• Subject is 18 years of age or older.
• Subject has an ECOG performance status of less than or equal to 1.
• Subject must understand and sign the study specific informed consent.
• Subject may have received chemotherapy or other therapy after harvest of tumor and prior to enrollment. Subjects who have achieved complete response following chemotherapy are still eligible for participation
• Subject is platinum-sensitive (progression-free interval ≥ 6 months prior to recent recurrence) or platinum-resistant (progression-free interval \< 6 months prior to recent recurrence).
• Subject has recovered from toxicities of prior chemotherapy or other therapy (to grade 2 or less).
• Subject may have received prior investigational therapy (including immune therapy).
• Subject may have received prior hormonal therapy.
• Subject may have received prior radiation therapy (except to inguinal region) but must have completed such therapy prior to enrollment.
• Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing. Subjects with bowel resections at surgery who enroll in cohort 2 will begin protocol at least 42 days after surgery if debulking surgery had comprised of bowel resection or other bowel surgery.
• Subjects who screen fails can be re-enrolled if the causation of the screen fail has been corrected.

You may not qualify if:

• Subject for whom tumor lysate does not meet release criteria
• Subject has a positive serum Yo antibody
• Subject whose groins are not accessible.
• Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included.
• Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included.
• Subject has positive test result at the screening visit for one or more of the following:
• HTLV-1/2
• Anti-HIV 1 Antibody (α-HIV-1)
• Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.
• Subject has renal insufficiency as defined by a serum creatinine greater than 2.2 mg/dl or BUN greater than 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
• Subject has proteinuria greater than 3.5 gm over 24 hrs are not eligible for the study (cohort 2 only)
• Subject with liver failure as defined by a serum total bilirubin greater than 2.0 and/or serum transaminases greater than 3X the upper limits of normal.
• Subject has hematopoietic failure at baseline as defined by one of the following:
• Platelets less than 100,000/ mm3
• WBC less than 2,500/mm3

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Ovarian Cancer Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Chiang CL, Maier DA, Kandalaft LE, Brennan AL, Lanitis E, Ye Q, Levine BL, Czerniecki BJ, Powell DJ Jr, Coukos G. Optimizing parameters for clinical-scale production of high IL-12 secreting dendritic cells pulsed with oxidized whole tumor cell lysate. J Transl Med. 2011 Nov 14;9:198. doi: 10.1186/1479-5876-9-198.

  PMID: 22082029 DERIVED

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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 Design

• Study Type: interventional
• Phase: early phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: May 1, 2010
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-04

Locations

US (1)