Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21231


Purpose:

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.


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 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


NCT ID:

NCT00003890


Primary Contact:

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


Backup Contact:

N/A


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: September 23, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.