A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
MG 98
Treatment Study
Summary
Study start date: February 22, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google MapsOttawa Regional Cancer Centre
Ottawa, Canada