Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00134186
First received: August 22, 2005
Last updated: March 2, 2007
Last verified: March 2007

August 22, 2005
March 2, 2007
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Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC
Complete list of historical versions of study NCT00134186 on ClinicalTrials.gov Archive Site
  • 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
  • Clinical benefit rate (CR, PR, SD)
  • Time to progression
  • Progression-free survival
  • Overall survival and survival at 6 and 12 months
  • Duration of clinical response
Not Provided
Not Provided
 
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Renal Cell
  • Urogenital Neoplasms
  • Urologic Neoplasms
  • Kidney Neoplasms
Drug: motexafin gadolinium
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00134186
PCYC-0219
Not Provided
Not Provided
Pharmacyclics
Not Provided
Principal Investigator: Robert J Amato, D.O. Methodist Hospital Genitourinary Oncology
Pharmacyclics
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP