Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer - Full Text View

Sponsor:	AVAX Technologies
Information provided by:	AVAX Technologies
ClinicalTrials.gov Identifier:	NCT00660101

Purpose

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.

Condition	Intervention	Phase
Adenocarcinoma of the Ovary	Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by AVAX Technologies:

Primary Outcome Measures:

Cell-mediated immunity to autologous tumor cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	April 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 5 million autologous, DNP-modified ovarian cancer cells	Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine Autologous, DNP-modified ovarian cancer cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
2: Experimental 2.5 million autologous, DNP-modified ovarian cancer cells	Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine Autologous, DNP-modified ovarian cancer cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
3: Experimental 0.5 million autologous, DNP-modified ovarian cancer cells	Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine Autologous, DNP-modified ovarian cancer cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months

Hide Detailed Description

Detailed Description:

To study the toxicity, safety and DTH response of DNP-modified autologous ovarian tumor cell vaccine and the DTH response to unmodified ovarian tumor cells in patients with relapsed ovarian cancer:

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: 3-4

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Screening Phase

Stage III or IV adenocarcinoma of ovary that has relapsed following original platinum-based chemotherapy followed by at least 1, but no more than 2 salvage chemotherapy regimens
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:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660101

Locations

United States, Illinois
Cancer Treatment Centers of America (CTCA-Midwestern)	Recruiting
Zion, Illinois, United States, 60099
Contact: Joy Jardinico, RN 847-731-4143 joy-jardinico@ctca-hope.com
Principal Investigator: Sybilann Williams, MD

Sponsors and Collaborators

AVAX Technologies

Investigators

Study Director:

Francois Martelet, MD

AVAX Technologies

More Information

Additional Information:

AVAX Technologies This link exits the ClinicalTrials.gov site

Cancer Treatment Centers of America This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2003 Dec 22.

Responsible Party:	AVAX Technologies ( Francois Martelet, MD - Chief Executive Officere )
Study ID Numbers:	A/100/0501
Study First Received:	April 16, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00660101 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AVAX Technologies:

ovarian cancer
vaccine
immunotherapy
autologous

Additional relevant MeSH terms:

Ovarian Neoplasms
Neoplasms by Histologic Type
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Carcinoma

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009