IM-862 in Treating Patients With Recurrent Ovarian Cancer

NCT ID: NCT00003773

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-28
• Study Completion Date: 2001-08-31

Brief Summary

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.

Detailed Description

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 toxicity.

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

Conditions

Ovarian Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

oglufanide disodium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agustin Garcia, MD

Role: STUDY_CHAIR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

LAC-USC-5O984

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1503

Identifier Type: -

Identifier Source: secondary_id

CDR0000066900 (5O-98-4)

Identifier Type: -

Identifier Source: org_study_id