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MG98 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00003890
First received: June 2, 2000
Last updated: November 7, 2010
Last verified: March 2010
History of Changes
  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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: MG 98
 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by NCIC Clinical Trials Group:

Estimated Enrollment: 20
Study Start Date: February 1999
Study Completion Date: September 2008
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003890

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00003890     History of Changes
Other Study ID Numbers: I125, CAN-NCIC-IND125, METHYL-MG98-002, CDR0000067059
Study First Received: June 2, 2000
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013