We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134186
First Posted: August 24, 2005
Last Update Posted: March 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmacyclics LLC.
  Purpose
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 Intervention Phase
Carcinoma, Renal Cell Urogenital Neoplasms Urologic Neoplasms Kidney Neoplasms Drug: motexafin gadolinium Phase 2

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Pharmacyclics LLC.:

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

Estimated Enrollment: 43
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

ClinicalTrials.gov Identifier: NCT00134186     History of Changes
Other Study ID Numbers: PCYC-0219
First Submitted: August 22, 2005
First Posted: August 24, 2005
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
Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents