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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma of the Ovary

In brief

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.

Key facts

Study ID

NCT00660101

Run by

AVAX Technologies

People needed

34

Starts

2008-06-01

Expected to finish

2016-01-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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