MG98 in Treating Patients With Advanced Solid Tumors

NCIC Clinical Trials Group

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: MG 98

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00003890

CDR0000067059 (Other Identifier)

I125

CAN-NCIC-IND125 (Other Identifier)

METHYL-MG98-002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)