- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574483
Treatment of Advanced Renal Cell Carcinoma With Quinacrine
An Open-label, Fixed-dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma
Study Overview
Detailed Description
Approximately 31,000 new cases of renal cell carcinoma (RCC) occur each year in the United States, with a death rate of about 11,600 annually. Many patients present with advanced or unresectable disease, and up to 30% of patients who are treated with nephrectomy will relapse. The 5 year survival rate for metastatic renal RCC is estimated at < 10%. Surgical resection of discernible disease is the only potentially curative treatment. No significant improvement in survival has been demonstrated for patients with metastatic RCC who have been treated with systemic hormonal, chemotherapeutic, and radiation therapy. Interferon alpha has about a 15% objective response rate in appropriately selected patients. Administration of interleukin 2 (IL 2) has shown a similar response rate; however, approximately 5% of highly selected patients had durable complete remissions.
Recent studies demonstrated that RCC cells harbor abnormalities of the von Hippel-Lindau (VHL) gene, playing a key role in the stimulation of angiogenesis by vascular endothelial growth factor (VEGF) in this highly vascularized tumor. The novel agents sunitinib (Sutent) and sorafenib (Nexavar) are approved by the US Food and Drug Administration (FDA) for the treatment of advanced RCC, and both bevacizumab (Avastin) and temsirolimus have shown significant activity in treatment-naïve patients. Prolonged progression-free survival has been reported with sorafenib and sunitinib in randomized, controlled phase 2 and 3 studies, and improved survival has been reported with temsirolimus in poor-risk patients in a phase 3 randomized study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Albany, New York, United States, 12208
- Community Care Physicians
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North Carolina
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Charlotte, North Carolina, United States, 28207
- ClinWorks Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed RCC with clear cell predominance.
- Subjects must provide written informed .
- Subjects must be at least 18 years old.
- Subjects must have at least 1 measurable lesion.
- Subjects must have metastatic, locally advanced or unresectable RCC.
- Subjects must have received ≥ 1 prior systemic regimen for RCC.
- All prior cancer therapy, including radiation, surgery, and systemic (hormonal, chemotherapeutic, and immunotherapeutic) therapy, must be completed at least 4 weeks before the baseline visit.
- Subjects must be capable of adhering to the study visit schedule and other protocol requirements.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Subjects must have:
- Absolute neutrophil count (ANC)> 1,500/uL
- Hemoglobin > 10.0 g/dL
- Platelets ≥ 100,000/uL
- Serum creatinine < 2.0 mg/dL
- Subjects must have adequate hepatic function, as defined by a bilirubin level of ≤ 1.5 times the upper limit of the normal range (ULN) and an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level of ≤ 3 times the ULN (or ≤ 5 times the ULN if liver metastases are present).
- Women of childbearing potential must have a negative serum pregnancy test at the screening visit and throughout the study.
- Sexually active women and men must agree to use a medically acceptable form of contraception.
Exclusion Criteria:
- Subjects who have a history of any malignancy (other than excised basal cell carcinoma or cervical intraepithelial neoplasia) within the 5 years of baseline visit.
- Subjects who have received any anticancer agents, treatment (chemotherapy, targeted agents, radiation, hormones), or investigational agents within 30 days of the baseline visit.
- Subjects who have untreated brain metastases.
- Subjects who have a history of hypersensitivity reaction to quinacrine or other acridine derivatives (e.g. Cognex).
- Subjects who have any clinically significant hematological, endocrine, cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal (GI), or neurological disease (including any history of seizure).
- Subjects who have a history of porphyria or psoriasis.
- Subjects who have documented glucose-6-phosphate dehydrogenase deficiency.
- Subjects who have a history of noninfectious (toxic, autoimmune) hepatitis.
- Subjects who have a history of schizophrenia, bipolar disorder, or any psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects who have a history of dermatitis as an allergic/toxic reaction to any medication.
- Subjects who have any grade 2 sensory neuropathy.
- Subjects who have a QTcF (Fredericia) of > 450 msec.
- Subjects who have New York Heart Association (NYHA) class 3 or 4 heart failure.
- Subjects who had a myocardial infarction or acute coronary syndrome within 6 months of the baseline visit.
- Subjects who require anti-arrhythmic treatment with amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning Automatic Implantable Cardio-Defibrillator (AICD) implanted.
- Subjects who are immunocompromised, including those known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Unblinded treatment arm
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100 mg day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor response
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to tumor progression
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: John H Gordon, PhD, Cleveland BioLabs
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Antinematodal Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Quinacrine
Other Study ID Numbers
- CBL-DD-07-C-H-2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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