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An Open-Label, Fixed-Dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

An Open-Label, Fixed-Dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma

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.

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

- 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

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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Tumor response

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

John H Gordon, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Cleveland BioLabs


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

January 2008

Related Keywords:

  • Renal Cell Carcinoma
  • Renal cell carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



Community Care PhysiciansAlbany, New York  12208
ClinWorks Cancer Research CenterCharlotte, North Carolina  28207