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Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine


Phase 2
18 Years
N/A
Not Enrolling
Female
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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Berd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000066382

NCT ID:

NCT00003386

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

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
Community Hospital of Los Gatos Los Gatos, California  95032
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Evanston Evanston, Illinois  60201
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
CCOP - Sooner State Tulsa, Oklahoma  74136
Radiation Oncology Branch Bethesda, Maryland  20892