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

• Sponsor: Pharmacyclics LLC. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00134186
• Collaborator: (none)
• Enrollment: 43
• Location: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Pharmacyclics LLC.

Investigators

• Principal Investigator: Robert J Amato, D.O., Methodist Hospital Genitourinary Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00134186
• Other Study ID Numbers: PCYC-0219
• First Posted: Aug 24, 2005
• Last Update Posted: Mar 5, 2007
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: Kidney cancer; Renal cell carcinoma; Motexafin gadolinium
• Additional relevant MeSH terms: Carcinoma; Neoplasms; Carcinoma, Renal Cell; Kidney Neoplasms; Urogenital Neoplasms; Urologic Neoplasms; Motexafin gadolinium

Study Results

No Results Posted as of Mar 5, 2007