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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	NCI-94-C-0023C NCI-MB-320, NCI-T93-0042N, T93-0042

Objectives

I.  Determine the maximally tolerated dose of interleukin-6 (IL-6) when given 
with granulocyte-macrophage colony stimulating factor (GM-CSF - 5 mcg/kg/day) 
following high-dose carboplatin (CBDCA - 600 mg/sqm every 28 days) in patients 
with recurrent ovarian cancer.

II.  Determine whether IL-6 in combination with GM-CSF alters the pattern of 
myelosuppression associated with high-dose CBDCA in these patients and whether 
the dose-intensity and/or cumulative dose of CBDCA may be increased.

III.  Characterize the toxicities of this regimen.

Entry Criteria

Disease Characteristics:

Biopsy-proven epithelial ovarian cancer (as determined by the
NCI Pathology Lab)

Recurrent disease required
  Prior therapy with a platinum-based regimen required

     No platinum-refractory patients (i.e., manifesting
     progressive disease during platinum-based therapy or
     within 6 months of completion of a platinum-based regimen)

  Prior intraperitoneal P32 allowed

No germ cell and/or borderline histologies

No CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:
  At least 2 weeks since cytokine therapy

Chemotherapy:
  See Disease Characteristics
  At least 4 weeks since chemotherapy, with recovery from all
     toxicity required

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior pelvic or whole abdominal radiotherapy
  At least 4 weeks since radiotherapy, with recovery from all
     toxicity required

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0 or 1

Hematopoietic:
  (within 14 days prior to entry)
  WBC more than 3,000
  AGC more than 1,500
  Platelets more than 100,000

Hepatic:
  (within 14 days prior to entry)
  Bilirubin no greater than 1.5 mg/dl
  Transaminases no more than 3 x ULN
  Normal coagulation parameters
     No concomitant anticoagulant therapy (e.g., heparin or
     coumadin) that prolongs PT or PTT

Renal:
  (within 14 days prior to entry)
  Creatinine clearance at least 45 ml/min
  No uncorrected ureteral obstruction

Cardiovascular:
  No history of or evidence for the following:
     Coronary heart disease
     CHF
     Arrhythmia requiring therapy
  No history of thrombotic episodes

Pulmonary:
  No moderate or severe intrinsic pulmonary dysfunction (e.g.,
  dyspnea with minimal to moderate exercise)

Other:
  No pre-existing neurologic dysfunction greater than grade 1
     (exclusive of mild vibratory delay)
  No concurrent use of steroids
  No diabetes mellitus
  No recent history of GI bleeding or heme-positive stool
  No history of autoimmune disease
  No HIV positivity
  No prior second malignancy except curatively treated
     nonmelanomatous skin cancer

Expected Enrollment

At least 3 patients will be treated at each dose studied.

Outline

Nonrandomized study.

Single-Agent Chemotherapy with Hematopoietic Stimulation.  Carboplatin, CBDCA, 
NSC-241240; with Granulocyte-Macrophage Colony Stimulating Factor (Schering), 
GM-CSF, NSC-643496; Interleukin-6 (Sandoz), IL-6, NSC-643497.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Eddie Reed, MD, Protocol chair(Contact information may not be current)		Ph: 304-293-4500; 877-427-2894