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Talabostat in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

talabostat mesylate

enzyme inhibitor therapy

flow cytometry

laboratory biomarker analysis

non-specific immune-modulator therapy

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

19 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

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
- The following are considered nonmeasurable disease:
  - Small lesions (longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan)
  - Bone lesions
  - Leptomeningeal disease
  - Ascites
  - Pleural or pericardial effusion
  - Lymphangitis cutis or pulmonis
  - Abdominal masses that are not confirmed and followed by imaging techniques
  - Cystic lesions
Progressed after ≥ 1 multikinase inhibitor regimen (i.e., sorafenib tosylate or sunitinib malate)
No history of CNS or brain metastasis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
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)
AST and 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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Talabostat

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate

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

Secondary Outcome Measures

Dose-limiting toxicity

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

Adverse events

Adverse events as assessed by NCI CTCAE v3.0

Full Information

NCT ID

NCT00489710

First Posted

June 20, 2007

Last Updated

August 18, 2023

Sponsor

University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT00489710

Brief Title

Talabostat in Treating Patients With Metastatic Kidney Cancer

Official Title

A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

safety reasons

Study Start Date

December 2006 (Anticipated)

Primary Completion Date

May 30, 2007 (Actual)

Study Completion Date

May 30, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Talabostat

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

talabostat mesylate

Other Intervention Name(s)

Val-boroPro

Intervention Type

Biological

Intervention Name(s)

enzyme inhibitor therapy

Intervention Type

Diagnostic Test

Intervention Name(s)

flow cytometry

Intervention Type

Diagnostic Test

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Biological

Intervention Name(s)

non-specific immune-modulator therapy

Primary Outcome Measure Information:

Title

Objective response rate

Description

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 Outcome Measure Information:

Title

Dose-limiting toxicity

Description

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.

Title

Adverse events

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Hauke, MD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Talabostat in Treating Patients With Metastatic Kidney Cancer

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