Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

IM-862 in Treating Patients With Recurrent Ovarian Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI LAC-USC-5O984 NCI-G99-1503, NCT00003773

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.

Entry 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

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 drugs

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

Expected Enrollment

A total of 20-70 evaluable patients will be accrued for this study within 6-9 
months.

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 toxicity.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Agustin Garcia, MD, Protocol chair(Contact information may not be current)		Ph: 323-865-0470; 800-865-0102 Email: aagarcia@hsc.usc.edu

Registry Information
Official Title		Phase I Study of Escalating Doses of IM-862 in Patients with Ovarian Cancer
Trial Start Date		1999-02-08
Registered in ClinicalTrials.gov		NCT00003773
Date Submitted to PDQ		1999-02-10
Information Last Verified		2001-01-01