Treatment of Advanced Renal Cell Carcinoma With Quinacrine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00574483
Recruitment Status : Withdrawn (reevaluation of compound development)
First Posted : December 17, 2007
Last Update Posted : August 3, 2015
Information provided by:
Cleveland BioLabs

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: quinacrine Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Fixed-dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma
Study Start Date : November 2007
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Unblinded treatment arm
Drug: quinacrine
100 mg day
Other Name: CBLC102

Primary Outcome Measures :
  1. Tumor response [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Time to tumor progression [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    1. Absolute neutrophil count (ANC)> 1,500/uL
    2. Hemoglobin > 10.0 g/dL
    3. Platelets ≥ 100,000/uL
    4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00574483

United States, New York
Community Care Physicians
Albany, New York, United States, 12208
United States, North Carolina
ClinWorks Cancer Research Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Cleveland BioLabs
Study Director: John H Gordon, PhD Cleveland BioLabs

Responsible Party: John H. Gordon, Cleveland BioLabs, Inc Identifier: NCT00574483     History of Changes
Other Study ID Numbers: CBL-DD-07-C-H-2002
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: January 2008

Keywords provided by Cleveland BioLabs:
Renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Anticestodal Agents
Antiplatyhelmintic Agents
Antiparasitic Agents
Anti-Infective Agents
Antiprotozoal Agents
Antinematodal Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action