Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003386

Enrollment

Unknown

Registered

2004-04-23

Start date

1999-07-31

Completion date

Unknown

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Brief summary

RATIONALE: Vaccines made from tumor tissue may make the body build an immune response and kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV ovarian epithelial cancer.

Detailed description

OBJECTIVES: I. Determine whether patients with surgically debulked ovarian epithelial cancer develop delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine. II. Assess the toxic effects of this regimen in these patients. III. Determine the feasibility of conducting a group wide vaccine study. OUTLINE: Patients undergo a standard debulking procedure with the tumor tissue being sent to Thomas Jefferson University. Patients then receive six courses of combination chemotherapy consisting of either paclitaxel and cisplatin or paclitaxel and carboplatin. Vaccine therapy must commence within 4-12 weeks of completion of chemotherapy. Patients are tested for delayed-type hypersensitivity (DTH) on day -7. Cyclophosphamide IV is administered on day 0. Dinitrophenyl (DNP)-modified autologous ovarian epithelial cell vaccine and BCG adjuvant are injected once a week beginning on day 3 and continuing for 6 weeks. DTH testing is repeated at week 8. Booster vaccine injections are administered at 6 and 12 months if patient is disease free. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Interventions

BIOLOGICALBCG vaccine

BIOLOGICALautologous tumor cell vaccine

DRUGcarboplatin

DRUGcisplatin

DRUGcyclophosphamide

DRUGpaclitaxel

OTHERdinitrophenyl

PROCEDUREsurgical procedure

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: Surgically debulked stage III or IV ovarian epithelial cancer Must be able to obtain adequate number of viable cells from excised tumor mass Must have received 6 courses of combination chemotherapy comprised of either paclitaxel and cisplatin OR paclitaxel and carboplatin Must be clinically tumor free following completion of chemotherapy (i.e., no metastasis by physical examination and CT of the abdomen and pelvis and serum CA-125 less than 35 IU/L) Not on a Phase III GOG protocol PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0 or 1 Hematopoietic: Hematocrit at least 25% WBC at least 3,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No active infections HIV negative Hepatitis B surface antigen negative Hepatitis C antibody negative No active autoimmune disease No prior invasive malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics 4-12 weeks since prior chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 months since prior major field radiotherapy Surgery: See Disease Characteristics

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026