A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Ross C. Donehower, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
I125
NCT ID:
NCT00003890
Start Date:
February 1999
Completion Date:
September 2008
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
