Renal Cell CarcinomaPhase 2NCT00574483
Treatment of Advanced Renal Cell Carcinoma With Quinacrine
A Phase 2 study testing quinacrine in people with Renal Cell Carcinoma, run by Cleveland BioLabs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- quinacrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Community Care Physicians
Albany, New York, 12208
ClinWorks Cancer Research Center
Charlotte, North Carolina, 28207
About this study
Official title: An Open-label, Fixed-dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma
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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- quinacrine
- Keywords
- Renal cell carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quinacrineDrug
Also called CBLC102
100 mg day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Unblinded treatment arm Receives: Drug: quinacrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Measured: 6 months
Secondary outcomes (1)
Time to tumor progression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2008 (estimated)
- Study completionJan 2008 (estimated)
Why it stopped: reevaluation of compound development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland BioLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John H Gordon, PhD, Study director, Cleveland BioLabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574483
- Sponsor's protocol ID
- CBL-DD-07-C-H-2002
- Status last verified
- Jan 2008
- First submitted
- 13 Dec 2007
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00574483
- Acronym / sponsor ID
- CBL-DD-07-C-H-2002
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: reevaluation of compound development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cleveland BioLabsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Jan 2008 (estimated)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: quinacrineUnblinded treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quinacrineAlso: CBLC102100 mg day | Drug | 1 |
Primary outcome
Tumor response
Time frame: 6 months
1 secondary outcome
Time to tumor progression
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John H Gordon, PhD study director
Cleveland BioLabs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing quinacrine in people with Renal Cell Carcinoma, run by Cleveland BioLabs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.