Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

MG98 in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over CAN-NCIC-IND125 METHYL-MG98-002, NCT00003890, IND125

Objectives

1. Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.
2. Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.
3. Evaluate the effectiveness of this treatment regimen in these patients.

Entry Criteria

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

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

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

Expected Enrollment

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

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.

Stewart DJ, Donehower RC, Eisenhauer EA, et al.: A phase I pharmacokinetic and pharmacodynamic study of the DNA methyltransferase 1 inhibitor MG98 administered twice weekly. Ann Oncol 14 (5): 766-74, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Ross Donehower, MD, Protocol chair		Ph: 410-955-8838 Email: donehro@jhmi.edu

Registry Information
Official Title		A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients with Advanced Cancer
Trial Start Date		1999-02-22
Registered in ClinicalTrials.gov		NCT00003890
Date Submitted to PDQ		1999-05-06
Information Last Verified		2000-10-01