NCT00006384

Brief Summary

RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor. Interferon alfa-2b may interfere with the growth of the cancer cells. Combining interferon alfa-2b with SU5416 may be an effective treatment for kidney cancer. PURPOSE: Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b in treating patients who have unresectable or metastatic kidney cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

October 4, 2000

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2000

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

December 24, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

Enrollment Period

6.3 years

First QC Date

October 4, 2000

Last Update Submit

October 18, 2011

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Interventions

recombinant interferon alfaBIOLOGICAL
semaxanibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic renal cell carcinoma Measurable or evaluable disease Prior nephrectomy allowed if documented disease progression prior to study No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease by ECG or physical examination No myocardial infarction or severe/unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No documented hypersensitivity to any excipients (Cremophor EL, ethanol, or polyethylene glycol) of SU5416 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior interleukin-2 and recovered No other prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy to measurable lesions Surgery: See Disease Characteristics More than 3 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Lara PN Jr, Quinn DI, Margolin K, Meyers FJ, Longmate J, Frankel P, Mack PC, Turrell C, Valk P, Rao J, Buckley P, Wun T, Gosselin R, Galvin I, Gumerlock PH, Lenz HJ, Doroshow JH, Gandara DR; California Cancer Consortium. SU5416 plus interferon alpha in advanced renal cell carcinoma: a phase II California Cancer Consortium Study with biological and imaging correlates of angiogenesis inhibition. Clin Cancer Res. 2003 Oct 15;9(13):4772-81.

    PMID: 14581348RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Interferon-alphaSemaxinib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Primo N. Lara, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

December 24, 2003

Study Start

November 1, 2000

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

US(3)