MG98 in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003890
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : November 9, 2010
Information provided by:
Canadian Cancer Trials Group

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
Unspecified Adult Solid Tumor, Protocol Specific Drug: MG 98 Phase 1

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : February 1999
Actual Study Completion Date : September 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • PTT normal


  • 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)


  • Creatinine no greater than 1.25 times ULN
  • Proteinuria less than 2+ (no greater than 500 mg in a 24 hour urinalysis)


  • 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


Biologic therapy:

  • No concurrent colony stimulating factors unless evidence of neutropenic infection


  • 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


  • At least 4 weeks since prior radiotherapy and recovered
  • Concurrent palliative radiotherapy allowed


  • At least 2 weeks since prior major surgery


  • At least 3 weeks since prior investigational drug therapy
  • No other concurrent investigational drug or anticancer therapy
  • No concurrent coumadin or heparin therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003890

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
NCIC Clinical Trials Group
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications of Results: Identifier: NCT00003890     History of Changes
Other Study ID Numbers: I125
CDR0000067059 ( Other Identifier: PDQ )
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
unspecified adult solid tumor, protocol specific