Treatment of Advanced Renal Cell Carcinoma With Quinacrine

NCT00574483 | Withdrawn Phase 2

• 1 other identifier: CBL-DD-07-C-H-2002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Cell Carcinoma

Keywords

Renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Tumor response

  6 months

Secondary Outcomes (1)

• Time to tumor progression

  6 months

Study Arms (1)

1

EXPERIMENTAL

Unblinded treatment arm

Drug: quinacrine

Interventions

quinacrine DRUG

100 mg day

Also known as: CBLC102

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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.

Sponsors & Collaborators

• Cleveland BioLabs: lead

Study Sites (2)

Community Care Physicians

Albany, New York, 12208, United States

Location

ClinWorks Cancer Research Center

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Quinacrine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John H Gordon, PhD

  Cleveland BioLabs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 3, 2015

Record last verified: 2008-01

Locations

US (2)