Back to resultsStudy of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
Primary Purpose
Carcinoma, Renal Cell, Urogenital Neoplasms, Urologic Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
motexafin gadolinium
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Kidney cancer, Renal cell carcinoma, Motexafin gadolinium
Eligibility Criteria
Inclusion Criteria: ≥ 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 Exclusion Criteria: 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
Sites / Locations
- Methodist Hospital
Outcomes
Primary Outcome Measures
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00134186
Brief Title
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
Official Title
Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Pharmacyclics LLC.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Urogenital Neoplasms, Urologic Neoplasms, Kidney Neoplasms
Keywords
Kidney cancer, Renal cell carcinoma, Motexafin gadolinium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Primary Outcome Measure Information:
Title
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Secondary Outcome Measure Information:
Title
Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
Title
Time to progression
Title
Progression-free survival
Title
Overall survival and survival at 6 and 12 months
Title
Duration of clinical response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Amato, D.O.
Organizational Affiliation
Methodist Hospital Genitourinary Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
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