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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134186

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

No publications provided

ClinicalTrials.gov Identifier: NCT00134186     History of Changes
Other Study ID Numbers: PCYC-0219
Study First Received: August 22, 2005
Last Updated: March 2, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Carcinoma
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
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014