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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003386 |
Purpose
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 | Intervention | 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 II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine |
| Study Start Date: | July 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Show 60 Study Locations| Study Chair: | David Berd, MD | Kimmel Cancer Center (KCC) |
More Information
| Study ID Numbers: | CDR0000066382, GOG-9802 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003386 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
|
BCG Vaccine Immunologic Factors Gonadal Disorders Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Genital Diseases, Female Cisplatin Ovarian Cancer Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Genital Neoplasms, Female |
Adjuvants, Immunologic Endocrine System Diseases Carboplatin Antimitotic Agents Ovarian Epithelial Cancer Immunosuppressive Agents Carcinoma Paclitaxel Tubulin Modulators Endocrinopathy Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
|
BCG Vaccine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Mitosis Modulators Genital Neoplasms, Female Adjuvants, Immunologic Endocrine System Diseases Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |
