IM-862 in Treating Patients With Recurrent Ovarian Cancer

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

oglufanide disodium

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 drugs

Sites / Locations

USC/Norris Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003773

First Posted

November 1, 1999

Last Updated

May 20, 2014

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003773

Brief Title

IM-862 in Treating Patients With Recurrent Ovarian Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

February 1999 (undefined)

Primary Completion Date

July 2000 (Actual)

Study Completion Date

August 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

oglufanide disodium

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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 drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agustin Garcia, MD

Organizational Affiliation

University of Southern California

Official's Role

Study Chair

Facility Information:

Facility Name

USC/Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033-0800

Country

United States

Ovarian Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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