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

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ClinicalTrials.gov Identifier: NCT00134186
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : March 5, 2007
Information provided by:
Pharmacyclics LLC.

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Urogenital Neoplasms Urologic Neoplasms Kidney Neoplasms Drug: motexafin gadolinium Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)

Secondary Outcome Measures :
  1. Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
  2. Time to progression
  3. Progression-free survival
  4. Overall survival and survival at 6 and 12 months
  5. Duration of clinical response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134186

United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pharmacyclics LLC.
Principal Investigator: Robert J Amato, D.O. Methodist Hospital Genitourinary Oncology

ClinicalTrials.gov Identifier: NCT00134186     History of Changes
Other Study ID Numbers: PCYC-0219
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: March 5, 2007
Last Verified: March 2007

Keywords provided by Pharmacyclics LLC.:
Kidney cancer
Renal cell carcinoma
Motexafin gadolinium

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents