RPI.4610 in Treating Patients With Metastatic Kidney Cancer

A Phase II, Open-Label, Multicenter Trial of Angiozyme in Subjects With Metastatic Renal Cell Cancer

RATIONALE: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have metastatic kidney cancer.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Biological: anti-FLT-1 ribozyme

Detailed Description

OBJECTIVES: I. Determine the response rate of patients with metastatic renal cell cancer treated with RPI.4610. II. Determine the percentage of these patients with stable disease at 16 weeks after starting treatment with this drug. III. Assess the safety and tolerability of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive RPI.4610 subcutaneously daily. Treatment continues for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment after 16 weeks. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS: Histologically confirmed clear cell renal cell cancer Stage IV Measurable disease Bone metastases may not be only measurable lesions Failed prior interleukin-2 (IL-2) therapy (with or without interferon) or ineligible or intolerant of IL-2 Prior nephrectomy (radical, partial, or laparoscopic) at least 4 weeks ago No CNS metastases on CT scan or MRI of head

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.5 g/dL No history of bleeding disorder Hepatic: AST or ALT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN (unless history of Gilbert's syndrome) Alkaline phosphatase no greater than 2.5 times ULN PT no greater than 15 sec INR no greater than 1.5 No history of cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No uncontrolled hypertension, defined as newly diagnosed but untreated or treated but with diastolic blood pressure at least 95 mmHg or systolic blood pressure at least 160 mmHg Other: HIV negative No systemic infection requiring antibiotics within the past 28 days No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No alcohol or drug abuse within the past 2 years No other medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior IL-2 At least 6 months since prior biotherapy for metastases (e.g., vaccines, matrix metalloproteinase inhibitors, or antibody therapy) No prior antiangiogenic agent, including thalidomide, or experimental antiangiogenic agents No concurrent immunotherapy No other concurrent biotherapy Chemotherapy: No prior chemotherapy for metastatic renal cell cancer No concurrent chemotherapy Endocrine therapy: No concurrent estrogens or other hormonal therapy including androgens Concurrent replacement doses of steroids allowed provided stable for the past 28 doses Radiotherapy: At least 8 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery Other: At least 4 weeks since prior investigational drugs No other concurrent investigational drugs No concurrent immunosuppressive medications No concurrent warfarin, heparin, low molecular weight heparin, or other anticoagulant agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT

Collaborators and Investigators

• Sponsor: Ribozyome

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: July 11, 2001
• First Submitted That Met QC Criteria: February 13, 2004
• First Posted (Estimate): February 16, 2004

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 25, 2013
• Last Verified: May 1, 2002

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; clear cell renal cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: CDR0000068739; UCLA-001201501; RPI-0004; NCI-G01-1975