MG98 in Treating Patients With Advanced Solid Tumors

NCIC Clinical Trials Group19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

MG 98DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Data from ClinicalTrials.gov

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