Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy

NCT00551265 | Withdrawn

• 4 other identifiers: GOG-0243NCI-2009-00607CDR0000570624U10CA027469
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial is studying the side effects of oregovomab and to see how well it works with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that responded to second-line chemotherapy. Monoclonal antibodies, such as oregovomab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether oregovomab is more effective when given together with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Conditions

Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma; Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Frequency and severity of adverse events as assessed by NCI CTCAE v3.0

  Up to 30 days after final treatment

• Serum human anti-murine antibodies (HAMA) as assessed by enzyme-linked immunosorbent assay (ELISA)

  At approximately 14 weeks after initial treatment

Secondary Outcomes (4)

• Duration of time from first response to first recurrence

  Up to 5 years

• Duration of time from second response to second recurrence

  Up to 5 years

• Frequency and magnitude of patients who have a delayed-type hypersensitivity (DTH) response to oregovomab, tetanus, mumps, and Candida as assessed by DTH skin testing

  Baseline to 14 weeks

• Serum HAMA and anti-idiotype antibodies as assessed by ELISA over the course of treatment

  At approximately 14 weeks after initial treatment

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo delayed-type hypersensitivity (DTH) skin testing with oregovomab and a standard anergy panel (i.e., mumps, Candida, and tetanus toxoid) on day 0 (at baseline) and at week 14. The skin test response is measured 48 hours later. Patients receive cyclophosphamide IV on day 6 and oregovomab IV over 20 minutes on day 9 or 10. Patients then receive oregovomab alone at weeks 6 and 10 and then every 12 weeks for up to 2 years (10 doses) in the absence of disease progression or unacceptable toxicity.

Drug: Cyclophosphamide; Procedure: Laboratory Biomarker Analysis; Biological: Oregovomab

Arm II

ACTIVE COMPARATOR

Patients undergo DTH skin testing and receive oregovomab as in arm I.

Procedure: Laboratory Biomarker Analysis; Biological: Oregovomab

Interventions

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Arm I

Laboratory Biomarker Analysis PROCEDURE

Correlative studies

Arm I; Arm II

Oregovomab BIOLOGICAL

Given IV

Also known as: B43.13, MoAb B43.13, Monoclonal Antibody B43.13, OvaRex, OvaRex Monoclonal Antibody B43.13

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal adenocarcinoma * Histologic documentation of the original primary tumor is required via pathology report * FIGO stage III-IV disease * Must have received 5-8 courses of front-line taxane- and platinum-based chemotherapy OR treatment on a first-line Gynecologic Oncology Group (GOG) protocol AND must have become clinically free of disease as measured by serum CA-125 level, CT scan, or physical examination * Must have documentation of a defined progression-free interval after front-line therapy, as measured from the date of initiation of front-line chemotherapy to the date of initiation of second-line chemotherapy * Relapsed disease (prior to starting second-line chemotherapy), defined by 1 of the following: doubling of serum CA-125 level confirmed by measurements taken 1 week apart (CA-125 level should have been elevated to at least double the level seen during the first complete response); identification of a new lesion by CT/MRI scan or physical examination * Must have completed 5-8 courses of second-line taxane- and platinum-based chemotherapy 4-8 weeks ago * Second-line chemotherapy must not have been started before clear evidence of disease recurrence was documented using RECIST criteria * Achieved complete clinical response to second-line chemotherapy with no symptoms suggestive of persistent disease, defined by the following: normal physical examination; reduction from the peak serum CA-125 level to a normal value of \>= 5 U/mL; complete regression of recurrent lesions by CT scan of the abdomen/pelvis * No low malignant potential tumors or noninvasive disease * GOG performance status 0-1 * ANC \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 8.0 g/dL * Creatinine =\< 1.5 times upper limit of normal (ULN) * Bilirubin =\< 1.5 times ULN * AST =\< 2.5 times ULN * Alkaline phosphatase =\< 2.5 times ULN * No known allergy to murine proteins, documented anaphylactic reaction to any drug, or intolerance to cyclophosphamide * No active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, or ankylosing spondylitis) * No recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia * No acquired, hereditary, or congenital immunodeficiencies * No other concurrent uncontrolled diseases * No contraindications to pressor agents * No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer * No prior cancer treatment that would contraindicate study therapy * No concurrent chronic treatment with immunosuppressive drugs (e.g., cyclosporine, adrenocorticotropic hormone \[ACTH\], or systemic corticosteroids)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Cyclophosphamide; oregovomab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Robert Edwards

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

US (1)