Treatment of Advanced Renal Cell Carcinoma With Quinacrine

Withdrawn before enrolling · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The overall response to standard therapies and to the newer antiangiogenesis therapies is not curative, and treatment-associated toxicities may be severe. Therefore, continued evaluation of therapies, with different mechanisms of action, is needed for patients with metastatic RCC.

Key facts

Study ID

NCT00574483

Run by

Cleveland BioLabs

People needed

0

Starts

2007-11-01

Expected to finish

2008-01-01

Last updated by the study team

2015-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Care Physicians — Albany, New York, United States
• ClinWorks Cancer Research Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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