Clinical trial · Interventional
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALVAC-hB7.1 | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| recombinant interferon gamma | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ALVAC-hB7.1, recombinant interferon gamma)
- description
- Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone.
- interventionNames
- Biological: ALVAC-hB7.1
- Biological: recombinant interferon gamma
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Autologous tumor cell cytotoxicity lymphocyte (CTL)
- timeFrame
- Up to 7 years
- measure
- Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR
- timeFrame
- Up to 7 years
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ovarian epithelial carcinoma * Previously treated with an adequate course of platinum based chemotherapy * Evidence of intraabdominal disease * No significant adhesions * Performance status - Zubrod 0-2 * Lymphocyte count at least 500/mm\^3 * Bilirubin no greater than 1.5 mg/dL * SGOT less than 2.5 times upper limit of normal * Creatinine no greater than 1.5 mg/dL * No major disorder of the cardiovascular system * No major disorder of the pulmonary system * Not pregnant or nursing * Fertile patients must use effective contraception * Successful placement of peritoneal catheter * No overt autoimmune disease * No concurrent chronic steroid therapy * No prior radiotherapy * Prior surgery allowed * Recovered from prior therapy
References
Publications (0)
Data not yet available