Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 to 70 AECM-9202054 NCI-V92-0080

Objectives

I.  Evaluate the safety of daily subcutaneous granulocyte-macrophage colony 
stimulating factor/interleukin-3 S. cerevisiae fusion protein (PIXY321) 
following chemotherapy with cyclophosphamide/carboplatin (CTX/CBDCA) in 
patients with advanced ovarian cancer.

II.  Determine the MTD and/or optimum biologic dose of PIXY321 given after 
CTX/CBDCA in patients with advanced ovarian cancer.

Entry Criteria

Disease Characteristics:

Histologically diagnosed, Stage II/III/IV epithelial ovarian
carcinoma

Prior/Concurrent Therapy:

Biologic therapy:
  No prior colony stimulating factor therapy (including GM-CSF,
     G-CSF, IL-3, IL-2, or interferon)
  No concurrent immunotherapy

Chemotherapy:
  No prior chemotherapy
  No concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy
  No concurrent radiotherapy

Surgery:
  Prior cytoreductive surgery, as feasible, required

Other:
  At least 4 weeks since treatment with any investigational
     agent
  No concurrent treatment with any medication that may
     interfere with interpretation of study results (e.g.,
     steroids, lithium, immunosuppressive or myelosuppressive
     agents)

Patient Characteristics:

Age:
  18 to 70

Performance status:
  Karnofsky 70-100%

Life expectancy:
  At least 3 months

Hematopoietic:
  ANC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  SGOT/SGPT no greater than 2 x ULN

Renal:
  Creatinine no greater than 1.5 mg/dl
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  No significant cardiac disease within previous 6 months
  No history of MI within previous 6 months
  No CHF within previous 6 months
  No uncontrolled hypertension

Pulmonary:
  No asthma (even if controlled with medication)

Other:
  No HBsAg positivity
  No known HIV positivity
  No significant active infection (e.g., pneumonia,
     peritonitis, wound abscess)
  No other serious intercurrent illness (e.g., uncontrolled
     metabolic disease such as diabetes mellitus,
     hypothyroidism)
  No dementia or altered mental status that would preclude
     informed consent
  No second malignancy except:
     Curatively treated nonmelanomatous skin cancer
     Curatively treated in situ cervical carcinoma
  No pregnant women (negative pregnancy test required of
     fertile women within 1 week of entry)
  Effective contraception required of fertile patients

Expected Enrollment

15 to 20 patients will be treated, with a possible 6 additional patients 
treated at the OBD.  The study is expected to be completed in 6-12 months.

Outline

Nonrandomized study.

2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation.  
Cyclophosphamide, CTX, NSC-26271; Carboplatin, CBDCA, NSC-141540; with 
Granulocyte-Macrophage Colony Stimulating Factor/Interleukin-3 S. cerevisiae 
fusion protein (Immunex), PIXY321.

Runowicz CD, Mandeli J, Speyer J, et al.: Phase I/II study of PIXY321 in combination with cyclophosphamide (CTX) and carboplatin (CP) in the treatment of patients (PTS) with ovarian cancer (OC). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-825, 260, 1993.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Scott Wadler, MD, Protocol chair(Contact information may not be current)		Ph: 718-904-2754