Expired Study
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Baltimore, Maryland 21231


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Ross C. Donehower, MD
Sidney Kimmel Comprehensive Cancer Center

Backup Contact:


Location Contact:

Baltimore, Maryland 21231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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