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MG98 in Treating Patients With Advanced Solid Tumors

Sponsor
NCIC Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003890
Collaborator
(none)
19
Enrollment
2
Locations
115
Actual Duration (Months)
9.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
  • Drug: MG 98
 Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.

  • Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.

  • Evaluate the effectiveness of this treatment regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

The dose of MG98 is escalated in cohorts of 1-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Patients are followed at week 4, then at least every 3 months until relapse of disease.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 10-12 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
Actual Study Start Date :
Feb 22, 1999
Actual Primary Completion Date :
Sep 27, 2001
Actual Study Completion Date :
Sep 22, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically or cytologically proven advanced solid tumor unresponsive to existing therapy or for which no curative therapy exists

    • Evidence of disease in addition to tumor marker elevation

    • CNS metastases allowed, if adequately treated and symptoms controlled for greater than 4 months

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:

    • Absolute granulocyte count at least 1,500/mm3

    • Platelet count at least 100,000/mm3

    • PTT normal

    Hepatic:

    • Bilirubin no greater than 1.25 times upper limit of normal (ULN)

    • SGOT or SGPT no greater than 3 times ULN (4 times ULN for liver metastases)

    Renal:

    • Creatinine no greater than 1.25 times ULN

    • Proteinuria less than 2+ (no greater than 500 mg in a 24 hour urinalysis)

    Other:

    • No active infection

    • No other serious systemic disease

    • No known hypersensitivity to oligodeoxynucleotides

    • Adequate venous access

    • No known condition (e.g., psychological, geographical) that would prevent compliance

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 3 months after the study

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No concurrent colony stimulating factors unless evidence of neutropenic infection
    Chemotherapy:

    • No more than 3 prior chemotherapy regimens

    • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered

    • At least 1 year since prior high dose chemotherapy with bone marrow or stem cell support

    • No concurrent chemotherapy

    Endocrine therapy:

    • Prior hormonal therapy allowed

    • No concurrent hormonal therapy

    Radiotherapy:

    • At least 4 weeks since prior radiotherapy and recovered

    • Concurrent palliative radiotherapy allowed

    Surgery:
    • At least 2 weeks since prior major surgery
    Other:

    • At least 3 weeks since prior investigational drug therapy

    • No other concurrent investigational drug or anticancer therapy

    • No concurrent coumadin or heparin therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    2 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4

    Sponsors and Collaborators

    • NCIC Clinical Trials Group

    Investigators

    • Study Chair: Ross C. Donehower, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NCIC Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT00003890
    Other Study ID Numbers:
    • I125
    • CAN-NCIC-IND125
    • METHYL-MG98-002
    • CDR0000067059
    First Posted:
    Aug 20, 2003
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by NCIC Clinical Trials Group
    unspecified adult solid tumor, protocol specific

    Study Results

    No Results Posted as of Apr 6, 2020