Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer
OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse:
1 other identifier
interventional
34
1 country
3
Brief Summary
To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2008
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedDecember 3, 2015
December 1, 2015
7.5 years
April 16, 2008
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cell-mediated immunity to autologous tumor cells
3 months
Secondary Outcomes (1)
Safety
9 months
Study Arms (3)
1
EXPERIMENTAL5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
2
EXPERIMENTAL2.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
3
EXPERIMENTAL0.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
Interventions
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
Eligibility Criteria
You may qualify if:
- Screening Phase
- Stage III or IV adenocarcinoma of ovary
- Candidate for surgery to excise the tumor
- Signed informed consent for tumor acquisition
- Treatment Phase
- At least 18 years of age
- Standard surgical debulking to maximum extent possible
- Adequate amount of tumor tissue obtained from surgical debulking to prepare a series of vaccines and skin test materials.
- Administration of intraperitoneal chemotherapy following surgical debulking Intraperitoneal drug to consist of a taxane (paclitaxel or docetaxel) Dose of taxane: paclitaxel=60-75 mg/m2 / weekly x 4 or docetaxel = 25 mg/m2 - weekly x 4
- Vaccines and DTH materials pass lot release
- Minimum of 2 weeks and maximum of 6 weeks following last dose of intraperitoneal chemotherapy
- Immunocompetent, as determined by anergy panel performed 1 week after last dose of intraperitoneal chemotherapy (baseline PPD+ patients allowed)
- Expected survival of at least 6 months
- Karnofsky performance status ³ 80
- Signed informed consent for protocol participation
You may not qualify if:
- Alkaline phosphatase \> 2.5 x ULN
- Total bilirubin \> 2.0 mg/dL
- Creatinine \> 2.0 mg/dL
- Hemoglobin \< 10.0 g/dL
- WBC \< 3,000 /mm3
- Platelet count \< 100,000/mm3
- Major field radiotherapy within 6 months prior to participation in the study
- Brain metastases, unless successfully treated at least 6 months prior to entry
- Prior immunotherapy (interferons, tumor necrosis factor, other cytokines \[e.g., interleukins\], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study
- Prior splenectomy
- Concurrent use of systemic steroids (Note: Topical steroid therapies \[applied to the skin\] are not contraindicated for participation in the study, provided these are not applied to either arm. Inhaled aerosol steroids are not contraindicated for participation in the study.)
- Concurrent use of immunosuppressive drugs
- Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)
- Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix
- Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cancer Treatment Centers of America (CTCA-Midwestern)
Zion, Illinois, 60099, United States
Cancer Treatment Centers of America (CTCA-Southwestern)
Tulsa, Oklahoma, 74133, United States
Cancer Treatment Centers of America (ERMC)
Philadelphia, Pennsylvania, 19124, United States
Related Publications (2)
Dunton CJ, Carlson JA, King SA, Bloome E, Neufeld J, Berd D. Immunological and clinical effects of autologous hapten-modified vaccine in patients with advanced ovarian carcinoma., 19: Abstract 1828 ed 2000. p. 466a.
BACKGROUNDBerd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22.
PMID: 14691123BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henry E Schea
AVAX Technologies
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 17, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
December 3, 2015
Record last verified: 2015-12