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A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 HopkinsBaltimore, Maryland  21231-2410