NCT00389285

Brief Summary

The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 27, 2009

Status Verified

May 1, 2009

Enrollment Period

2.6 years

First QC Date

October 16, 2006

Last Update Submit

May 26, 2009

Conditions

Carcinoma, Renal Cell

Keywords

Carcinoma, renal cellinterleukin-21sorafenibImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Safety profile, including incidence and severity of adverse events

    During treatment and 28 days after last dose of rIL-21

Secondary Outcomes (3)

  • Objective response rate at recommended dose of rIL-21

    Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached

  • Progression-free survival at recommended dose of rIL-21

    Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached

  • Pharmacokinetic profiles of rIL-21 and sorafenib

    rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing

Interventions

rIL-21 onlyDRUG

Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course

rIL-21 + sorafenibDRUG

Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of RCC of predominantly clear cell histology
  • Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)
  • At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)
  • Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)

You may not qualify if:

  • Presence of acute infection or other significant systemic illness
  • Central nervous system involvement by malignancy
  • History of other cancer within 5 years
  • Previously received rIL-21 or sorafenib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • Bhatia S, Curti B, Ernstoff MS, Gordon M, Heath EI, Miller WH Jr, Puzanov I, Quinn DI, Flaig TW, VanVeldhuizen P, Byrnes-Blake K, Freeman JA, Bittner R, Hunder N, Souza S, Thompson JA. Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study. J Immunother Cancer. 2014 Jan 27;2:2. doi: 10.1186/2051-1426-2-2. eCollection 2014.

    PMID: 24829759DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Naomi Hunder, MD

    ZymoGenetics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 18, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 27, 2009

Record last verified: 2009-05

Locations

US(3)