Sirolimus and Gold Sodium Thiomalate in Treating Patients With Advanced Squamous Non-Small Cell Lung Cancer

NCT01383668 | Withdrawn Phase 1 DMC

• 2 other identifiers: MC102ANCI-2011-00968
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase I trial studies the side effects and best dose of sirolimus and gold sodium thiomalate when given together in treating patients with advanced squamous non-small cell lung cancer (NSCLC). Sirolimus and gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Conditions

Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Maximally tolerated dose (MTD) of ATM plus sirolimus

  MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.

  28 days

Secondary Outcomes (5)

• To describe the adverse event profile associated with the treatment combination of ATM plus sirolimus.

  Up to 3 months after completion of study treatment

• Confirmed response rate

  Every 6 weeks

• Overall survival time

  Up to 3 months after completion of study treatment

• Progression-free survival (PFS)

  Up to 3 months after completion of study treatment

• Time-to-progression (TTP)

  Up to 3 months after completion of study treatment

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive sirolimus PO QD on days 1-28 and gold sodium thiomalate IM on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: sirolimus; Drug: gold sodium thiomalate; Other: pharmacological study; Genetic: RNA analysis; Genetic: polymerase chain reaction

Interventions

sirolimus DRUG

Given PO

Also known as: AY 22989, Rapamune, rapamycin, SLM

Treatment (enzyme inhibitor therapy)

gold sodium thiomalate DRUG

Given IM

Also known as: Aurolate, Myochrysine, sodium aurothiomalate

Treatment (enzyme inhibitor therapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (enzyme inhibitor therapy)

RNA analysis GENETIC

Correlative studies

Treatment (enzyme inhibitor therapy)

polymerase chain reaction GENETIC

Correlative studies

Also known as: PCR

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

• Cohort I (Dose Escalation) only: must have histologic proof of an advanced, solid tumor that is now unresectable
• Cohort II (MTD) only
• Patients must have platinum-refractory NSCLC (platinum-refractory defined as either disease progression either during or within 6 months of completion of first-line platinum-based chemotherapy)
• Must have measurable disease
• Must have received at least one prior approved chemotherapeutic regimen unless there is no known, approved therapeutic regimen for their malignancy
• Must have evidence of disease progression within the preceding 6 months - Absolute neutrophil count (ANC) \>= 1500/uL
• Platelets (PLT) \>= 100,000/uL
• Total bilirubin =\< 1.5 x upper limit of normal (ULN)
• (Serum glutamic oxaloacetic transaminase \[SGOT\]) aspartate aminotransferase (AST) / (serum glutamic pyruvic transaminase \[SGPT\]) alanine transaminase (ALT) =\< 3 x ULN or (SGOT) AST / (SGPT) ALT =\< 5 x ULN if liver involvement
• Creatinine =\< 1.5 x ULN
• Fasting blood glucose =\< 126 mg/dL
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• Ability to provide informed consent
• Willingness to return to Mayo Clinic in Florida for follow-up
• Life expectancy \>= 84 days (3 months)

You may not qualify if:

• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Any of the following prior therapies:
• Chemotherapy =\< 28 days prior to registration
• Mitomycin C/nitrosoureas =\< 42 days prior to registration
• Immunotherapy =\< 28 days prior to registration
• Biologic therapy =\< 28 days prior to registration
• Radiation therapy =\< 28 days prior to registration
• Radiation to \> 25% of bone marrow
• Bevacizumab =\< 28 days prior to registration
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• New York Heart Association classification III or IV
• Known central nervous system (CNS) metastases or seizure disorder; patients with known brain metastases that have been successfully treated and stable for \>= 6 months without requirement for corticosteroids and without seizure activity will be eligible
• Patients with known diabetes mellitus unless well-controlled (fasting blood sugar \[FBS\] =\< 126mg/dL and hemoglobin \[Hb\]A1C =\< 7.0)
• Receiving therapeutic anticoagulation with warfarin; NOTE: prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed, provided that International Normalized Ratio (INR) \< 1.5; therapeutic anti-coagulation with low molecular weight heparin is allowed at time of registration

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sirolimus; Gold Sodium Thiomalate; Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Thiomalates; Malates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organogold Compounds; Organometallic Compounds; Sulfhydryl Compounds; Sulfur Compounds; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Michael Menefee

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: February 8, 2013
• Study Completion: February 8, 2013
• Last Updated: April 1, 2020

Record last verified: 2012-12