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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell, Urogenital Neoplasms, Urologic Neoplasms, Kidney Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Robert J Amato, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Methodist Hospital Genitourinary Oncology

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0219

NCT ID:

NCT00134186

Start Date:

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • Urogenital Neoplasms
  • Urologic Neoplasms
  • Kidney Neoplasms
  • Kidney cancer
  • Renal cell carcinoma
  • Motexafin gadolinium
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Urogenital Neoplasms
  • Urologic Neoplasms

Name

Location

Methodist Hospital Houston, Texas  77030