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	Closed	18 and over		CAN-NCIC-IND59 NCI-V91-0001, IND59

Objectives

I.  Establish an optimum dose and schedule for the daily subcutaneous 
administration of interleukin-3 (IL-3) in patients receiving standard-dose 
carboplatin as therapy for relapsed ovarian carcinoma.
II.  Compare, in individual patients, the laboratory and clinical aspects of 
myelosuppression documented during chemotherapy courses with vs. without IL-3.
III.  Correlate the laboratory and clinical aspects of myelosuppression with 
the incidence of febrile neutropenia or documented infection.
IV.  Document the safety and toxicity of IL-3 administered subcutaneously.

Entry Criteria

Disease Characteristics:

Clinically documented ovarian carcinoma in relapse following
first-line cisplatin- or carboplatin-containing chemotherapy

Histological diagnosis of epithelial ovarian cancer required,
including:
   Serous cystadenocarcinoma
   Mucinous cystadenocarcinoma
   Endometrioid
   Clear cell
   Undifferentiated
   Borderline (if chemotherapy considered best therapy)

Patients who progressed on first-line therapy or relapsed or
progressed within 2 months of completing first-line therapy
are excluded

No clinical evidence of CNS involvement

Prior/Concurrent Therapy:

At least 6 weeks since prior investigational therapy

Biologic therapy:
   At least 6 weeks since prior cytokine therapy

Chemotherapy:
   Must have failed prior first-line cisplatin- or
   carboplatin-containing chemotherapy

Endocrine therapy:
   Not specified

Radiotherapy:
   No prior radiotherapy for ovarian cancer

Surgery:
   Not specified

Other:
   Must have no requirement for systemic corticosteroids

Patient Characteristics:

Age:
   18 and over

Performance status:
   ECOG 0-2

Life expectancy:
   More than 3 months

Hematopoietic:
   AGC at least 1,500
   Platelets at least 150,000
   Peripheral blood smear normal (i.e., no evidence of
   underlying myelodysplastic syndrome)

Hepatic:
   Total bilirubin less than 1.5 x normal
   ALT and AST less than 2 x ULN
   PT and PTT normal

Renal:
   Creatinine no more than 1.5 x ULN

Cardiovascular:
   No ventricular dysrhythmia requiring therapy
   No CHF even if controlled

Other:
   Must be able to self-administer or receive daily sc
       injections
   Must have access to platelet transfusion or hospitalization
       within 24 hours
   No history of severe allergic reactions (e.g., anaphylaxis)
   HIV negative at entry
   No second malignancy within 5 years except curatively
       treated nonmelanomatous skin cancer
   No pregnant or lactating women
   Adequate contraception required of fertile women

Expected Enrollment

It is expected that 16 evaluable patients will be required to establish an 
optimum schedule during the initial phase of this study; if the protocol is 
amended to examine new IL-3 schedules, 4-8 additional patients may be accrued.

Outline

On entry, patients are alternately assigned to receive interleukin-3 during 
the first or second course.
Single-agent Chemotherapy with Hematologic Toxicity Attenuation.  Carboplatin, 
CBDCA, NSC-241240; with Recombinant Interleukin-3 (Immunex), IL-3.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

James J. Rusthoven, MD, Protocol chair		Ph: 905-648-7786 Email: jrusthov@6serv.com