Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

Ifosfamide With or Without O(6)-Benzylguanine in Treating Patients With Unresectable, Metastatic Solid Tumors

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This randomized phase I trial is studying the side effects and best dose of O(6)-benzylguanine when given together with ifosfamide and to see how well it works compared to ifosfamide alone in treating...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of O6-benzylguanine when administered with standard high-dose ifosfamide in patients with unresectable, metastatic solid tumors. II. Deter...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed solid tumor
  • Unresectable, metastatic disease
  • No primary tumors
  • Eligible for high-dose ifosfamide-based therapy
  • No known brain metastases
  • Performance status - ECOG 0-1
  • Performance status - Karnofsky 70-100%
  • More than 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal
  • Creatinine normal
  • Creatinine clearance ≥ 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to O6-benzylguanine or other study agents
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • More than 24 hours since prior colony-stimulating factors (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
  • No prior hematopoietic stem cell transplantation
  • No concurrent pegfilgrastim
  • No concurrent immunotherapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy
  • No concurrent hormonal therapy
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent therapeutic radiotherapy
  • More than 4 weeks since prior anticancer therapy
  • No more than 2 prior cytotoxic regimens
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    June 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT00086970

    Start Date

    June 1 2004

    Last Update

    January 24 2013

    Active Locations (1)

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

    Page 1 of 1 (1 locations)

    1

    University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States, 60637-1470