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Completed

NCT Number: NCT00134186

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

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).

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Methodist Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motexafin gadolinium

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study title

Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma

Important dates

First posted
Aug 24, 2005
Registry last updated
Mar 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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