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Status:

COMPLETED

3-AP in Treating Patients With Previously Untreated Locally Recurrent or Metastatic Renal Cell Carcinoma

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Kidney Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 3-AP i...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy of 3-AP (Triapine®), in terms of objective response rate, in patients with previously untreated locally recurrent or metastatic renal cell carcinoma. Se...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed renal cell carcinoma
  • Locally recurrent OR metastatic disease
  • Incurable by standard therapy
  • Clinically and/or radiologically measurable disease
  • At least 1 unidimensionally measurable lesion\* at least 20 mm by x-ray, physical exam, or non-spiral CT scan OR at least 10 mm by spiral CT scan
  • If the sole site of measurable disease is in a previously irradiated field, there must be documented disease progression at that site NOTE: \*Bone lesions are not considered measurable disease
  • No documented brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute granulocyte count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency\* NOTE: \*Screening for G6PD deficiency is required for patients of African, Asian, or Mediterranean descent
  • Hepatic
  • Bilirubin normal
  • AST or ALT no greater than 2.5 times upper limit of normal (ULN)
  • Renal
  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min
  • Cardiovascular
  • No myocardial infarction within the past 6 months
  • No symptomatic congestive heart failure
  • No unstable angina
  • No active cardiomyopathy
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • Pulmonary
  • No pulmonary disease requiring oxygen
  • Immunologic
  • HIV negative
  • No known hypersensitivity to compounds of similar chemical or biological composition to 3-AP (Triapine®)
  • No active uncontrolled or serious infection
  • No immunodeficiency
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor with no evidence of disease for at least 5 years
  • No history of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude giving informed consent or complying with study requirements
  • No active peptic ulcer disease
  • No other serious illness or medical condition that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 3 months since prior interferon for advanced or recurrent disease
  • No other prior immunotherapy for advanced or recurrent disease
  • No prior gene therapy
  • Chemotherapy
  • No prior systemic chemotherapy for advanced or recurrent disease
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered
  • Surgery
  • At least 2 weeks since prior major surgery
  • Other
  • No prior investigational anticancer agents
  • No other concurrent anticancer agents or therapy
  • No other concurrent investigational therapy
  • No concurrent anticoagulants
  • Concurrent nontherapeutic warfarin or heparin allowed

Exclusion

    Key Trial Info

    Start Date :

    May 11 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 22 2008

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00075660

    Start Date

    May 11 2004

    End Date

    September 22 2008

    Last Update

    August 4 2023

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Cross Cancer Institute

    Edmonton, Alberta, Canada, T6G 1Z2

    2

    British Columbia Cancer Agency

    Vancouver, British Columbia, Canada, V5Z 4E6

    3

    CancerCare Manitoba

    Winnipeg, Manitoba, Canada, R3E 0V9

    4

    Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, Canada, L8V 5C2