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

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ClinicalTrials.gov Identifier: NCT00003386
Recruitment Status : Terminated
First Posted : April 23, 2004
Last Update Posted : April 11, 2013
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: BCG vaccine Biological: autologous tumor cell vaccine Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: paclitaxel Other: dinitrophenyl Procedure: surgical procedure Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine
Study Start Date : July 1999
Primary Completion Date : April 2001

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003386

  Show 60 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: David Berd, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
More Information

ClinicalTrials.gov Identifier: NCT00003386     History of Changes
Other Study ID Numbers: CDR0000066382
First Posted: April 23, 2004    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: December 2008

Keywords provided by Gynecologic Oncology Group:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic