Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer
NCT ID: NCT00660101
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2008-06-30
2016-01-31
Brief Summary
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Detailed Description
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* To determine the tolerability and toxicity of the treatment regimen
* To determine whether O-Vax induces a DTH response to autologous, DNP-modified ovarian cancer cells
* To determine whether O-Vax induces a DTH response to autologous, unmodified ovarian cancer cells
Study Population: Patients with recurrent epithelial ovarian cancer whose therapeutic tumor surgery provides a mass which yields adequate tumor cells for vaccine preparation and delayed-type hypersensitivity (DTH) testing
Study Design: A Phase I/IIa double-blind, three-dose, multi-center study
Investigational Product: O-Vax: DNP-modified autologous ovarian tumor cell vaccine
Dosage Form: Cell suspension
Route of Administration: Intradermal
Dosage and Treatment Schedule: Prior to enrollment in the study, one dose of 5 x 106 modified and one dose of 5 x 106 unmodified autologous ovarian cancer cells will be administered, to establish a negative DTH response at baseline. Three dosing regimens will be used: 5 x 105, 2.5 x 106, or 5 x 106 DNP-modified autologous ovarian tumor cells. An initial dose of DNP-modified autologous ovarian tumor cells\* followed by cyclophosphamide then weekly doses of DNP-modified autologous ovarian tumor cells mixed with Bacillus of Calmette and Guérin (BCG) for 6 weeks, and completed with one dose of DNP-modified autologous ovarian tumor cells mixed with BCG as a 6 month booster if adequate cells
* count determined prior to aliquoting for cryopreservation
Endpoints: Treatment-emergent and related adverse events, serious adverse events, and Grade 3 and 4 laboratory abnormalities
Other Parameters:
* Delayed-type hypersensitivity skin reactions for assessing the induction of immune responses to DNP-modified and unmodified autologous ovarian tumor cells
* CA-125 levels
* Survival
* Exploratory analysis incorporating in vitro analysis of lymphocytes separated from patient blood samples
Duration of Treatment: Up to 6 months
Duration of Subject Participation in Study: Three months from the patient's last vaccine
Duration of Follow-up: Survival information will be collected via phone or visit on a quarterly basis for each patient beginning 30 days after the last scheduled visit
Number of Subjects Required to Meet Protocol Objectives: 42 evaluable subjects
Number of Study Centers: 4-5
Number of Individual Blood Draws: 13 draws over nine months
Volume of Blood Drawn: 11 Draws of 30 mL/draw (total 360 mL) and two draws of 50mL in heparinized tubes
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
2
2.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
3
0.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
Interventions
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OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Concurrent medical condition that would preclude compliance or immunologic response to study treatment
* Concurrent serious infection or other serious medical condition
* Receipt of any investigational medication within 4 weeks prior to participation in the study
* Known gentamicin sensitivity
* Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus, trichophyton (based upon availability), or PPD
* Vaccine lot release failure
18 Years
FEMALE
No
Sponsors
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AVAX Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Henry E Schea
Role: STUDY_DIRECTOR
AVAX Technologies
Locations
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Cancer Treatment Centers of America (CTCA-Midwestern)
Zion, Illinois, United States
Cancer Treatment Centers of America (CTCA-Southwestern)
Tulsa, Oklahoma, United States
Cancer Treatment Centers of America (ERMC)
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Berd 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.
Related Links
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AVAX Technologies
Cancer Treatment Centers of America
Other Identifiers
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A/100/0501
Identifier Type: -
Identifier Source: org_study_id