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

Primary Purpose

Adenocarcinoma of the Ovary

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Ovary focused on measuring ovarian cancer, vaccine, immunotherapy, autologous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Cancer Treatment Centers of America (CTCA-Midwestern)
Cancer Treatment Centers of America (CTCA-Southwestern)
Cancer Treatment Centers of America (ERMC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

2.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

0.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

Outcomes

Primary Outcome Measures

Cell-mediated immunity to autologous tumor cells

Secondary Outcome Measures

Safety

Full Information

NCT ID

NCT00660101

First Posted

April 16, 2008

Last Updated

December 2, 2015

Sponsor

AVAX Technologies

1. Study Identification

Unique Protocol Identification Number

NCT00660101

Brief Title

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

Official Title

OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse:

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AVAX Technologies

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Ovary

Keywords

ovarian cancer, vaccine, immunotherapy, autologous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

Arm Title

Arm Type

Experimental

Arm Description

2.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

Arm Title

Arm Type

Experimental

Arm Description

0.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells

Intervention Type

Biological

Intervention Name(s)

OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine

Other Intervention Name(s)

OVax, O-Vax

Intervention Description

OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months

Primary Outcome Measure Information:

Title

Cell-mediated immunity to autologous tumor cells

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Safety

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry E Schea

Organizational Affiliation

AVAX Technologies

Official's Role

Study Director

Facility Information:

Facility Name

Cancer Treatment Centers of America (CTCA-Midwestern)

City

Zion

State/Province

Illinois

ZIP/Postal Code

60099

Country

United States

Facility Name

Cancer Treatment Centers of America (CTCA-Southwestern)

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

Facility Name

Cancer Treatment Centers of America (ERMC)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19124

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

14691123

Citation

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.

Results Reference

background

Links:

URL

http://www.avax-tech.com

Description

AVAX Technologies

URL

http://www.cancercenter.com

Description

Cancer Treatment Centers of America

Learn more about this trial

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

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