Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-04

Study Completion Date

2009-01-07

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.

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Detailed Description

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Conditions

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Cancer Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

recombinant interleukin-21

Intervention Type DRUG

Administered i.v. in treatment cycles of 28 days.

caelyx (pegylated liposomal doxorubicin)

Intervention Type DRUG

Administered i.v. in treatment cycles of 28 days.

Interventions

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recombinant interleukin-21

Administered i.v. in treatment cycles of 28 days.

Intervention Type DRUG

caelyx (pegylated liposomal doxorubicin)

Administered i.v. in treatment cycles of 28 days.

Intervention Type DRUG

Other Intervention Names

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rIL-21 NN028

Eligibility Criteria

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Inclusion Criteria

* Advanced epithelial Ovarian Cancer (stage IIB-IV)
* Persistent or progressive disease after or relapse within one year of completion of first line therapy
* Measurable or assessable disease
* Eastern Cooperative Oncology Group status less than or equal to 2

Exclusion Criteria

* History of any other active malignancy
* Signs of CNS metastasis
* More than one prior chemotherapy regimen
* Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks
* First line chemotherapy completed at least 1 month prior to start of treatment

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No