Talabostat in Treating Patients With Metastatic Kidney Cancer
August 18, 2023 updated by: University of Nebraska
A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well talabostat works in treating patients with metastatic kidney cancer.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic renal cell carcinoma treated with talabostat mesylate.
- Determine the progression-free survival of patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Correlate changes in specific cytokine levels and peripheral blood flow cytometry with progression-free survival.
OUTLINE: This is a nonrandomized study.
Patients receive oral talabostat mesylate once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained from patients at baseline and after each course for biomarker correlative studies. Samples are analyzed for serum cytokines and chemokines and for T-cell subsets and natural killer (NK) cells by flow cytometry. Peripheral blood lymphocytes are obtained at baseline and after course 1 for future assessment by gene microarray analysis.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Pathologic diagnosis of renal cell carcinoma (clinical confirmation of metastatic disease required)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Progressed after ≥ 1 multikinase inhibitor regimen (i.e., sorafenib tosylate or sunitinib malate)
- No history of central nervous system or brain metastasis
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.5 g/dL (no packed red blood cell transfusions within the past 4 weeks) (epoetin alfa support allowed)
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (unless due to Gilbert's syndrome)
- aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 times ULN
- Creatinine < 2.0 mg/dL
- No active serious infections
- No other malignancy within the past 5 years except basal cell or nonmetastatic squamous cell skin cancer or carcinoma in situ of the cervix
- No comorbidity or concurrent condition that would interfere with protocol assessments or procedures
- No ongoing coagulopathy
- At least 4 weeks since prior systemic therapy and recovered
- Prior radiotherapy allowed as long as the lesion treated is not used to assess response
- No prior radiotherapy to > 50% of the bone marrow
- No prior radiotherapy to index lesions unless there is clearly progressive disease within the irradiated area OR measurable disease outside the irradiated area
Exclusion Criteria
- History of CNS or brain metastasis
- Pregnant, nursing or planning on becoming pregnant
- Active serious infections
- Malignancy within the past 5 years except basal cell or nonmetastatic squamous cell skin cancer or carcinoma in situ of the cervix
- comorbidity or concurrent condition that would interfere with protocol assessments or procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Talabostat
Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective response rate
Time Frame: After 9 and 12 evaluable patients (126 to 168 days of total treatment). Each course is 14 days and repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Evaluable patients are those that have completed 4 cycles of treatment.
|
After 9 and 12 evaluable patients (126 to 168 days of total treatment). Each course is 14 days and repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dose-limiting toxicity
Time Frame: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Any grade 3-4 non-haematological or grade 4 haematological toxicity at least possibly related to treatment
|
From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|
Adverse events
Time Frame: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Adverse events as assessed by NCI CTCAE v3.0
|
From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ralph Hauke, MD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2006
Primary Completion (Actual)
May 30, 2007
Study Completion (Actual)
May 30, 2007
Study Registration Dates
First Submitted
June 20, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimated)
June 21, 2007
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Enzyme Inhibitors
- Immunomodulating Agents
Other Study ID Numbers
- 0401-05-FB
- CDR0000549510 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.