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Clinical Trials/NCT00003890
NCT00003890CompletedPhase 1

A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

NCIC Clinical Trials Group2 sites in 2 countries19 target enrollmentStarted: February 22, 1999Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
19
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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:
  • •18 and over
  • •Performance status:
  • •Life expectancy:
  • •At least 12 weeks
  • •Hematopoietic:
  • •Absolute granulocyte count at least 1,500/mm3
  • •Platelet count at least 100,000/mm3
  • •PTT normal
  • •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)
  • •Creatinine no greater than 1.25 times ULN
  • •Proteinuria less than 2+ (no greater than 500 mg in a 24 hour urinalysis)
  • •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
  • •At least 2 weeks since prior major surgery
  • •At least 3 weeks since prior investigational drug therapy
  • •No other concurrent investigational drug or anticancer therapy
  • •No concurrent coumadin or heparin therapy

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (2)

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