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WithdrawnNCT00489710Updated Aug 22, 2023

Talabostat in Treating Patients With Metastatic Kidney Cancer

A Phase 2 interventional study of talabostat mesylate and enzyme inhibitor therapy in Kidney Cancer, sponsored by University of Nebraska. Withdrawn. Open to participants aged 19 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment

Why this study was withdrawn
safety reasons
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
19 Years to 120 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Kidney Cancer

Keywords

  • stage IV renal cell cancer
  • recurrent renal cell cancer
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

Browse Kidney Neoplasms studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Talabostat

    Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles

    Drug: talabostat mesylate · Biological: enzyme inhibitor therapy · Diagnostic Test: flow cytometry · Diagnostic Test: laboratory biomarker analysis · Biological: non-specific immune-modulator therapy

Interventions

  • Drugtalabostat mesylate

    Also known as: Val-boroPro

  • Biologicalenzyme inhibitor therapy
  • Diagnostic testflow cytometry
  • Diagnostic testlaboratory biomarker analysis
  • Biologicalnon-specific immune-modulator therapy
06

What researchers measure

Primary outcomes

  1. Objective response rate

    Evaluable patients are those that have completed 4 cycles of treatment.

    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.

Secondary outcomes

  1. Dose-limiting toxicity

    Any grade 3-4 non-haematological or grade 4 haematological toxicity at least possibly related to treatment

    Time frame: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

  2. Adverse events

    Adverse events as assessed by NCI CTCAE v3.0

    Time frame: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00489710
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Jun 21, 2007
Start date
Dec 2006 (estimated)
Primary completion
May 30, 2007
Completion
May 30, 2007
Last update
Aug 22, 2023

Study contacts

Ralph Hauke, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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