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Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer


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

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Trial Information

Phase I Dose Escalation Study to Evaluate the Safety of T138067-Sodium in Patients With Advanced Refractory Cancer


OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to
patients with advanced refractory cancer on a 28-day schedule and establish a dose for
further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these
patients. III. Determine the pharmacokinetic parameters after a single intravenous dose of
this agent in these patients. IV. Obtain safety data and preliminary efficacy information
after repetition of single doses of T138067 sodium in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV
over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total)
in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients
are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined
as the dose level where 2 of 3-6 patients experience DLT.

PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory cancer Must meet one
of the following criteria: - Failed at least 1 regimen of radiotherapy, chemotherapy, or
immunotherapy and not a candidate for a regimen of higher efficacy - Refractory to
existing standard therapy and not candidate for a regimen of higher efficacy - Advanced
malignancy for which there is no standard chemotherapy available No known brain metastases
or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time at least 30% of control
Partial thromboplastin time at least 30% of control Hepatic: Bilirubin less than 2 mg/dL
ALT and AST no greater than 2 times normal Alkaline phosphatase no greater than 2 times
normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial
infarction in the past 6 months Other: No immunodeficiency syndrome (acquired or
congenital) No uncontrolled infection No significant comorbidity that may compromise
participation in this study Not pregnant Effective contraception required of all fertile
patients during and until 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
since prior immunotherapy No concurrent immunotherapy or biologic response modifier
therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior
chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: At least 3 weeks since any prior major surgery Other: No
organ allograft At least 30 days since any prior investigational agents No concurrent
nonsteroidal antiinflammatory agents or aspirin No concurrent alternative therapies (i.e.,
herbal medicines, high doses of vitamins) No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-004

NCT ID:

NCT00003359

Start Date:

April 1998

Completion Date:

January 2001

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021