Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01624766
Other study ID # 2011-1043
Secondary ID NCI-2018-0184220
Status Completed
Phase Phase 1
First received
Last updated
Start date June 19, 2012
Est. completion date February 24, 2021

Study information

Verified date February 2021
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial studies the side effects and best dose of everolimus when given together with anakinra or denosumab in treating participants with cancers that have spread to other places in the body and have come back or aren't responding to treatment. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and the spread of cancer. Monoclonal antibodies, such as denosumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and anakinra or denosumab may work better in treating participants with advanced cancers.


Description:

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of anakinra or denosumab in combination with everolimus in patients with advanced cancers who progressed on standard therapy. SECONDARY OBJECTIVES: I. Preliminary assessment of antitumor efficacy of anakinra or denosumab in combination with everolimus in patients with advanced cancers. II. Assessment of the pharmacokinetic (PK) profile of anakinra or denosumab in combination with everolimus. III. Preliminary assessment of biomarkers. OUTLINE: This is a dose-escalation study of everolimus. Participants are assigned to 1 of 2 arms. ARM I: Participants receive everolimus orally (PO) daily and anakinra subcutaneously (SC) daily on days 1-28. Treatment repeats every 28 days in absence of disease progression or unacceptable toxicity. ARM II: Participants receive everolimus PO daily on days 1-28 and denosumab SC on day 1. Treatment repeats every 28 days in absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date February 24, 2021
Est. primary completion date February 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months. - Patients must be >= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >= 5 half-lives or >= 3 weeks form the last dose (whichever comes first). - Eastern Cooperative Oncology Group (ECOG) performance status =< 2. - Absolute neutrophil count (ANC) >= 1,000/mL. - Platelets >= 75,000/mL. - Creatinine clearance >= 35 ml/min. - Total bilirubin =< 2 X upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome). Exception for patients with liver metastasis: total bilirubin =< 3 x ULN. - Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 5 X ULN. Exception for patients with liver metastasis: ALT (SGPT) =< 8 X ULN. - Fasting lipid profile: cholesterol =< 350 mg/dL. - Fasting lipid profile: triglycerides =< 400 mg/dL. - Corrected calcium >= 8.4 mg/dL. - Phosphorus >= 2.5 mg/dL for denosumab. - Oral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy. - Negative tuberculosis quantiferon test for anakinra arm. - Negative serology for histoplasma, blastomycosis, and Coccidioidomycosis for anakinra arm. - Negative serology for active hepatitis B and C for anakinra arm. Patients with positive serology for hepatitis B might eligible if they are willing to take lamivudine preventive therapy. - Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose. - Patients must be able to understand and be willing to sign a written informed consent document. Exclusion Criteria: - Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. Treatment of pre-existing invasive fungal infections must be completed prior to starting treatment. - Patients with an active infection. - Pregnant or lactating women. - History of hypersensitivity to anakinra. - History of hypersensitivity to denosumab. - History of hypersensitivity to everolimus. - History of hypersensitivity to any component of the formulation. - Patients unwilling or unable to sign informed consent document. - Patients treated with TNF antagonists. - Patients with a history of active systemic fungal infection. - Patients with liver disease Child Pugh classification B and C.

Study Design


Intervention

Biological:
Anakinra
Given SC
Denosumab
Given SC
Drug:
Everolimus
Given PO

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of everolimus If more than 33% of patients enrolled at any particular dose level develop dose limiting toxicity (DLT), the treatment will continue at the dose level immediately below. If not more than 33% of the patients in the cohort develop DLT, this cohort will be considered the MTD. Only DLTs within course 1 (4 weeks) will be counted with respect to the dose-escalation algorithm. At 28 days
Primary Incidence of adverse events Describing the toxicity profile, descriptive statistics will be provided on the grade and type of toxicity by dose level. Up to 30 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03671226 - Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center N/A
Recruiting NCT05048160 - A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm Phase 1/Phase 2
Active, not recruiting NCT03287492 - RCT of QPS vs General Information Sheet N/A
Recruiting NCT01549067 - The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey N/A
Recruiting NCT04119037 - Cordotomy in Reducing Pain in Patients With Advanced Cancer N/A
Recruiting NCT04067336 - First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Recruiting NCT04585750 - The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) Phase 1/Phase 2
Completed NCT02823652 - Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer N/A
Completed NCT00244972 - Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer Phase 1
Recruiting NCT06297642 - TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. Phase 1
Active, not recruiting NCT01582191 - Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT03856060 - Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits N/A
Completed NCT04186884 - Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
Completed NCT02583269 - Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery Phase 1
Withdrawn NCT03868423 - Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Phase 2
Terminated NCT02940223 - Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer Phase 2
Active, not recruiting NCT01552434 - Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease Phase 1
Active, not recruiting NCT03021486 - Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer Phase 2/Phase 3
Recruiting NCT03203525 - Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer Phase 1
Not yet recruiting NCT06394713 - A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors Phase 1/Phase 2