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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 CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
Community Hospital of Los GatosLos Gatos, California  95032
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - EvanstonEvanston, Illinois  60201
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Sooner StateTulsa, Oklahoma  74136
Radiation Oncology BranchBethesda, Maryland  20892