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Trial · Interventional

CompletedPhase 1Registry data

IM-862 in Treating Patients With Recurrent Ovarian Cancer

NCTNCT00003773 (opens ClinicalTrials.gov in a new tab)Other idCDR0000066900 (5O-98-4)Other idLAC-USC-5O984Other idNCI-G99-1503
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Overview

Status
Completed
Phase
Phase 1
Enrollment
43 participants (actual)
Sponsor
University of Southern California · Other
Design
Not stated
Countries
1 country

United States

Start
Feb 1999
Primary completion
Jul 2000
Completion
Aug 2001
First posted
3 Jun 2004 (estimated)
Last update posted
22 May 2014 (estimated)
Conditions
Ovarian Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1999200020012002
  1. Ph 1

    IM-862 in Treating Patients With Recurrent Ovarian Cancer

    NCT00003773

    Feb 1999 to Aug 2001

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • oglufanide disodiumDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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