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Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine

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.

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David Berd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



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