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Home > "M" Clinical Trials Conditions > MG98 in Treating Patients With Advanced Solid Tumors  MG98 in Treating Patients With Advanced Solid Tumors
MG98 in Treating Patients With Advanced Solid Tumors
For Condition: Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors. II. Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population. III. Evaluate the effectiveness of this treatment regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RossDonehower, Study Chair, National Cancer Institute of Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000067059; CAN-NCIC-IND125,METHYL-MG98-002
Study Start Date: February 1999
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003890
Other Neoplasms Studies:
1. Cord Blood Stem Cell Transplantation Study (COBLT)
2. Phase I Study of HeFi-1 to Treat Cancers with CD30 Protein
3. Massage for the Treatment of Cancer-Related Pain
4. Anemia in Patients with a Non-Myeloid Malignancy
5. Studies of the Immune Response in Normal Subjects and Patients with Disorders of the Immune System
Related Studies:
Other Neoplasms Clinical Trials
Other Ontario Clinical Trials
Other Ottawa Clinical Trials
MG98 in Treating Patients With Advanced Solid Tumors
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