NCT00134186

Brief Summary

The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

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

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
Last Updated

March 5, 2007

Status Verified

March 1, 2007

First QC Date

August 22, 2005

Last Update Submit

March 2, 2007

Conditions

Carcinoma, Renal CellUrogenital NeoplasmsUrologic NeoplasmsKidney Neoplasms

Keywords

Kidney cancerRenal cell carcinomaMotexafin gadolinium

Outcome Measures

Primary Outcomes (1)

  • Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)

Secondary Outcomes (5)

  • Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])

  • Time to progression

  • Progression-free survival

  • Overall survival and survival at 6 and 12 months

  • Duration of clinical response

Interventions

motexafin gadoliniumDRUG

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years old
  • Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
  • Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
  • Measurable disease
  • Hemoglobin ≥ 9 mg/dL
  • ECOG performance status of 0, 1, or 2
  • Willing and able to provide written informed consent

You may not qualify if:

  • Inadequate bone marrow, renal and liver function by laboratory criteria
  • Absolute neutrophil count \< 1500/µL;
  • Platelet count \< 100,000/µL;
  • AST or ALT \> 2 x upper limit of normal (ULN);
  • Alkaline phosphatase \> 5 x ULN;
  • Total bilirubin \> 2 x ULN;
  • Creatinine \> 2.0 mg/dL.
  • Evidence of central nervous system metastases within past year
  • Uncontrolled hypertension
  • Known history of porphyria, G6PD deficiency or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellUrogenital NeoplasmsUrologic NeoplasmsKidney Neoplasms

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Robert J Amato, D.O.

    Methodist Hospital Genitourinary Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Last Updated

March 5, 2007

Record last verified: 2007-03

Locations

US(1)