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Adenocarcinoma of the OvaryPhase 1/2NCT00660101

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

A Phase 1/2 study testing OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine in people with Adenocarcinoma of the Ovary, run by AVAX Technologies at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Adenocarcinoma of the Ovary
What is being tested?
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
3 sitesUnited States
Study dates
Jun 2008to Jan 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Cancer Treatment Centers of America (ERMC)

    Philadelphia, Pennsylvania, 19124

  • Cancer Treatment Centers of America (CTCA-Southwestern)

    Tulsa, Oklahoma, 74133

  • Cancer Treatment Centers of America (CTCA-Midwestern)

    Zion, Illinois, 60099

Other trials in United States

About this study

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

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.

Read the 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

Being tested
OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
Keywords
ovarian cancer, vaccine, immunotherapy, autologous
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OVax: Autologous, DNP-Modified Ovarian Cancer VaccineBiological

    Also called OVax, O-Vax

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

Study groups in NCT00660101
Study groupRoleWhat they receive
1Experimental5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
Receives: Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
2Experimental2.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
Receives: Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
3Experimental0.5 million OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine cells
Receives: Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cell-mediated immunity to autologous tumor cells

    Measured: 3 months

Secondary outcomes (1)

  1. Safety

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2015 (estimated)
  4. Study completionJan 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00660101
Sponsor's protocol ID
A/100/0501
Status last verified
Dec 2015
First submitted
16 Apr 2008
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14691123

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine in people with Adenocarcinoma of the Ovary, run by AVAX Technologies at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell-mediated immunity to autologous tumor cells (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00660101, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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