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MG98 in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00003890   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes

June 2, 2000
July 23, 2008
February 1999
 
 
 
Complete list of historical versions of study NCT00003890 on ClinicalTrials.gov Archive Site
 
 
 
MG98 in Treating Patients With Advanced Solid Tumors
A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

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.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: MG 98
 
Stewart DJ, Donehower RC, Eisenhauer EA, Wainman N, Shah AK, Bonfils C, MacLeod AR, Besterman JM, Reid GK. A phase I pharmacokinetic and pharmacodynamic study of the DNA methyltransferase 1 inhibitor MG98 administered twice weekly. Ann Oncol. 2003 May;14(5):766-74.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
20
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00003890
 
CDR0000067059, CAN-NCIC-IND125, METHYL-MG98-002
NCIC Clinical Trials Group
 
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP