NCT00418496

Brief Summary

The primary objective of this study will be to determine the toxicity and Maximum Tolerated Dose (MTD) of the combination of high dose aldesleukin and sorafenib in previously untreated patients with metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic melanoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

November 8, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

6.3 years

First QC Date

January 2, 2007

Last Update Submit

February 17, 2017

Conditions

Renal CancerMelanoma

Keywords

UnresectableMetastatic

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    Determine the MTD for high dose (HD) aldesleukin and sorafenib in patients with metastatic or unresectable clear cell renal cell carcinoma and metastatic melanoma

    up to 1 year

Secondary Outcomes (2)

  • Determine the progression free survival.

    Up to 12 weeks

  • Evaluate in a preliminary manner the response rate.

    Up to 12 weeks

Study Arms (1)

Aldekleukin Plus Dose Escalation Sorafenib

EXPERIMENTAL

Patients will be admitted to a dedicated nursing unit for HD aldesleukin administration. Patients will receive bolus aldesleukin at a dose of 600,000 IU/Kg every eight hours on days 1-5 with a goal of 10-12 doses.

Drug: AldesleukinDrug: Sorafenib

Interventions

AldesleukinDRUG

600,000 IU/kg every 8 hours on days 1-5 (week 1) to a maximum of 12 doses. Another cycle of HD aldesleukin will be started on day 15 (week 3).

Also known as: Proleukin
Aldekleukin Plus Dose Escalation Sorafenib
SorafenibDRUG

To be initiated at a dose of 200 mg orally. Once it is determined that no further HD aldesleukin therapy will be given, sorafenib may be given daily at the FDA approved dose of 400 mg twice daily until there is lack of clinical benefit or intolerable side effects develop.

Also known as: Nexavar
Aldekleukin Plus Dose Escalation Sorafenib

Eligibility Criteria

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

You may qualify if:

  • Patients must have histologically or cytologically confirmed evidence of metastatic/ unresectable clear cell renal carcinoma.
  • Patients must have metastatic melanoma with no brain metastases.
  • Patients must have measurable disease.
  • No prior systemic treatment (One prior systemic treatment is allowed for metastatic melanoma patients. Excluded prior therapies include prior high dose aldesleukin, sorafenib and DTIC/TMZ.)
  • Age ≥ 18 years or older

You may not qualify if:

  • Patients who are undergoing or have undergone surgery S weeks.
  • Patients who are pregnant (because of possible side effects on the fetus) Effective contraception will be discussed with each patient.
  • Patients with uveal melanoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Monk P, Lam E, Mortazavi A, Kendra K, Lesinski GB, Mace TA, Geyer S, Carson WE 3rd, Tahiri S, Bhinder A, Clinton SK, Olencki T. A phase I study of high-dose interleukin-2 with sorafenib in patients with metastatic renal cell carcinoma and melanoma. J Immunother. 2014 Apr;37(3):180-6. doi: 10.1097/CJI.0000000000000023.

    PMID: 24598448RESULT

Related Links

MeSH Terms

Conditions

Kidney NeoplasmsMelanomaNeoplasm Metastasis

Interventions

aldesleukinSorafenib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • J. Paul Monk, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

November 8, 2006

Primary Completion

February 28, 2013

Study Completion

October 1, 2013

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

US(1)