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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134186
• Other study ID #: PCYC-0219
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: March 2, 2007

Study information

• Verified date: March 2007
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Neoplasms
• Urogenital Neoplasms
• Urologic Neoplasms

Intervention

Drug:
• motexafin gadolinium

Locations

Country	Name	City	State
United States	Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Secondary	Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
Secondary	Time to progression
Secondary	Progression-free survival
Secondary	Overall survival and survival at 6 and 12 months
Secondary	Duration of clinical response