Know Cancer

forgot password

A Phase I Study of Oral ILX23-7553 in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Study of Oral ILX23-7553 in Patients With Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of
ILX23-7553 in patients with refractory solid tumors. II. Determine the principal and dose
limiting toxicities of this treatment regimen in terms of duration and reversibility in this
patient population. III. Determine the preliminary evidence of antitumor activity with this
treatment regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive oral ILX23-7553 for
5 days. Treatment repeats every 2 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity. Patients are
followed monthly for at least 2 months.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 12-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor refractory
to conventional therapy or for which no standard therapy exists Measurable or evaluable

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0
mg/dL (regardless of liver metastases) SGOT/SGPT no greater than 2 times upper limit of
normal Renal: Creatinine no greater than 1.5 mg/dL Calcium no greater than 9.5 mg/dL No
nephrocalcinosis Cardiovascular: No congestive heart failure No angina or ischemia Other:
Ability to swallow or nasogastric or gastrostomy tube present Adequate organ and immune
system function No known hypersensitivity to ILX23-7553 or analogues HIV negative No
active uncontrolled infection No other severe disease or psychiatric disorder that would
preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No
concurrent curative antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: At
least 4 weeks since prior radiotherapy and recovered No concurrent curative radiotherapy
Surgery: At least 4 weeks since prior surgery and recovered Other: At least 30 days since
prior investigational agents At least 2 weeks since prior vitamin D, calcium
supplementation, or cholestyramine No concurrent vitamin D, calcium supplementation, or
cholestyramine No concurrent digoxin No concurrent hypercalcemia therapy (i.e.,
biphosphonates or insulin)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven Soignet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

December 2009

Related Keywords:

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



New Jersey Medical School Newark, New Jersey  07103-2714
Memorial Sloan-Kettering Cancer Center New York, New York  10021