RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have
recurrent ovarian cancer after treatment with chemotherapy and surgery.
OBJECTIVES: I. Determine the maximum tolerated dose of IM-862 administered intranasally in
patients with recurrent ovarian cancer. II. Determine the toxicity of this regimen in this
patient population. III. Obtain preliminary data regarding the efficacy of this drug in
these patients. IV. Evaluate the effect of this drug in serum levels of vascular endothelial
growth factor and transforming growth factor in this population.
OUTLINE: This is a dose escalation study. Patients receive IM-862 intranasally daily.
Treatment continues for 6 months in the absence of unacceptable toxicity or disease
progression. At the physician's discretion, further treatment may be given if the patient is
still responding after 6 months of treatment. The dose of IM-862 is escalated in cohorts of
10-20 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting
PROJECTED ACCRUAL: A total of 20-70 evaluable patients will be accrued for this study within
DISEASE CHARACTERISTICS: Histologically proven recurrent ovarian cancer Failed or relapsed
after cytoreductive surgery followed by a platinum-based chemotherapy regimen Measurable
or evaluable disease Recurrent disease manifested by isolated increased levels of CA-125
and no other evaluable disease eligible if CA-125 is at least 100
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT
and/or AST no greater than 2.5 times ULN Renal: Creatinine no greater than 2 times ULN
Neurological: No evidence of moderate peripheral neuropathy greater than grade 1 Other:
Not pregnant Fertile patients must use effective contraception No medical, social, or
psychological factors interfering with compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior IM-862 No concurrent biologic therapy
(e.g., interleukin-2 and interferons) Chemotherapy: See Disease Characteristics Recovered
from prior chemotherapy No concurrent antineoplastic cytotoxic agents Endocrine therapy:
Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: See Disease
Characteristics Recovered from prior surgery Other: No other concurrent investigational