MG98 in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00003890

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-22
• Study Completion Date: 2008-09-22

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MG 98

Intervention Type: DRUG

Eligibility Criteria

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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross C. Donehower, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Countries

United States; Canada

References

Stewart DJ, Donehower RC, Eisenhauer EA, Wainman N, Shah AK, Bonfils C, MacLeod AR, Besterman JM, Reid GK. A phase I pharmacokinetic and pharmacodynamic study of the DNA methyltransferase 1 inhibitor MG98 administered twice weekly. Ann Oncol. 2003 May;14(5):766-74. doi: 10.1093/annonc/mdg216.

Reference Type: RESULT

PMID: 12702532 (View on PubMed)

Other Identifiers

CAN-NCIC-IND125

Identifier Type: OTHER

Identifier Source: secondary_id

METHYL-MG98-002

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067059

Identifier Type: OTHER

Identifier Source: secondary_id

I125

Identifier Type: -

Identifier Source: org_study_id