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Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer

Phase 1
18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer

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
6-9 months.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:

CDR0000066900 (5O-98-4)



Start Date:

February 1999

Completion Date:

August 2001

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800