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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014